Proactive outcome monitoring and standardisation of physiotherapy stroke rehabilitation — A retrospective functional outcomes analysis of Accelerated Stroke Ambulation Programme (ASAP) (2024)

Background:

A clinical quality improvement programme named Accelerated Stroke Ambulation Programme (ASAP) was piloted in Physiotherapy Department of Tai Po Hospital from 1st October 2019 to 30th September 2020 and executed as a standard practice afterwards. The goal of ASAP was to facilitate early maximal walking ability of stroke patients in early rehabilitation phase. ASAP featured (1) proactive outcome monitoring and standardised process compliance monitoring by a patient database — Stroke Registry; (2) standardised mobility prediction by Reference Modified Rivermead Mobility Index (MRMI) Gain and (3) standardised intervention database — Stroke Treatment Library.

Objective:

To investigate the effectiveness of ASAP in an inpatient rehabilitation setting for stroke patients in terms of functional outcomes.

Methods:

The design was a retrospective comparative study to analyse the difference in functional outcomes of Pre-ASAP Group (1st October 2018 - 30th September 2019) and Post-ASAP Group (1st October 2020–30th September 2021). The primary outcome measures were MRMI, Berg’s Balance Scale (BBS), Modified Barthel Index (MBI), MRMI Gain, BBS Gain, MBI Gain, MRMI Efficiency, BBS Efficiency and MBI Efficiency.

Results:

There 348 subjects in Pre-ASAP Group and 281 subjects in Post-ASAP Group. Both groups had highly significant within-group improvement in MRMI, BBS and MBI ($p<0.001$). The MRMI Gain of Pre-ASAP Group and Post-ASAP Group was 6.32 and 7.42, respectively; and the difference was significant ($p<0.05$). The BBS Gain of Pre-ASAP Group and Post-ASAP Group was 8.17 and 9.70, respectively; and the difference was in margin of significance ($p=0.069$). The MBI Gain of Pre-ASAP Group and Post-ASAP Group was 10.69 and 11.96, respectively; but the difference was non-significant ($p=0.280$). The MRMI Efficiency, BBS Efficiency and MBI Efficiency of Post-ASAP Group were higher than Pre-ASAP Group but the difference was non-significant. The results of this study reflected that stroke rehabilitation programme with proactive outcome monitoring, standardised process compliance monitoring, standardised mobility prediction and standardised intervention database was practical in real clinical practice with better functional outcomes than traditional physiotherapy practice which were dominated by personal preference and experience of therapists.

Conclusion:

Proactive outcome monitoring, standardised process compliance monitoring, standardised mobility prediction and standardised intervention database may enhance the effectiveness in terms of functional outcomes of stroke rehabilitation programme.

Keywords: Physiotherapy, stroke, rehabilitation, standardisation, functional outcome

Control group: Traditional physiotherapy treatment

The Pre-ASAP Group was the control group of the study which received traditional physiotherapy treatments which were based on the corporate stroke rehabilitation protocol of Hong Kong Hospital Authority.⁶ The protocol was designed with reference to the International Classification of Functioning, Disability and Health framework of the World Health Organization⁷ that delineated the current practice patterns of physiotherapy intervention including limbs mobilisation, muscle tone normalisation, muscle strengthening, electrical muscle stimulation, transfer training, gait training and balance training for patients with stroke. The protocol allowed variations in clinical practice and ultimate decision about a particular clinical treatment depended on each individual patient’s condition, circumstances and clinical judgment of physiotherapists. The physiotherapy treatments were delivered by same team of physiotherapists from 5 to 7 days per week. The duration of each physiotherapy session was 60–90 min depended on patients’ tolerance and motivation.

Experimental group: Accelerated Stroke Ambulation Programme

The Post-ASAP Group was the experimental group in this study which received ASAP on top of traditional physiotherapy treatments. The goal of ASAP was to facilitate early maximal walking ability of stroke patients in early rehabilitation phase. ASAP features (1) proactive outcome monitoring and standardised process compliance monitoring by a patient database— Stroke Registry; (2) standardised mobility prediction by Reference MRMI Gain and (3) standardised intervention database— Stroke Treatment Library. The physiotherapy treatments were delivered by same team of physiotherapists from 5 to 7 days per week. The duration of each physiotherapy session was 60–90 min depended on patients’ tolerance and motivation.

Stroke Registry: Proactive outcome monitoring/Standardised process compliance monitoring

Stroke Registry was a longitudinal stroke rehabilitation database to bridge the gap between evidence-practice and clinical practice by big data concept.⁵ The function of Stroke Registry was proactively monitoring functional outcomes of patients and process compliance of interventions delivered to patients. It was in Excel format and contained patients’ clinical information such as patient characteristics, day since stroke, type of stroke, episode of stroke, premorbid mobility level, present mobility level, number of gym session received and discharge arrangement. The data of stroke patients were entered by their case therapists after baseline assessment, weekly reassessment and pre-discharge assessment. Stroke Registry could generate a Reference MRMI Gain of each patient after the entry of baseline assessment so as to provide proactive outcome monitoring of patients before they were discharged from the programme. As a standardised process compliance monitoring, Stroke Registry would provide treatment suggestion for two interventions, i.e. Knee–Ankle–Foot Orthoses (KAFO) and Robotic-Assisted Gait Training (RAGT) if patients fulfilled the preset criteria in Stroke Registry. The Stroke Registry also has a built-in Stroke Treatment Library to suggest suitable intervention to therapist.

Reference Modified Rivermead Mobility Index Gain: Standardised mobility prediction

MRMI Gain indicated the mobility improvement of subjects and was deviated from a mobility score— MRMI.⁸ Reference MRMI Gain was a clinical prediction model apply business intelligence concept to standardise the mobility prediction of stroke patients upon completion of the in-patient phase of stroke rehabilitation programme. The predict clinical outcome gave therapists a standardised objective goal in mobility training within the stroke rehabilitation programme. To achieve this function, Stroke Registry generates a Reference MRMI Gain from a preset formula which contained patients’ age, premorbid mobility level in term of Modified Functional Ambulation Category (MFAC) and admission mobility level in term of MRMI. The development of Reference MRMI Gain was based on past clinical data of patients discharged from our stroke rehabilitation programme from 2011 to 2018 ($n=4,136$). The correlation of Reference MRMI Gain and actual MRMI Gain was investigated and showed a moderate correlation (Pearson $\mathrm{\text{correlation}}=0.386$) between Reference MRMI Gain and Actual MRMI gain. Therefore, therapists and the stroke term could monitor the progress of stroke patients by compare the weekly MRMI to the Reference MRMI Gain and adjust the treatment parameters accordingly.

Stroke treatment library: Standardised intervention database

The aim of Stroke Treatment Library was to facilitate standardised intervention prescription to stroke patients with different mobility level by providing timely clinical decision support to therapists. It was a database with a basket of 85 selected physiotherapy interventions in video format located inside Stroke Registry. According to recent high-level evidence, the selection of intervention had priority to intensive high repetitive task/task-oriented/task-specific training.^9,10 In order to provide task difficulty matching, i.e. repetitive practice of movement tasks at the “just right” level of challenge,¹¹ the interventions were categorised from easy to hard level according to the scores (0–5) and sub-items (1–8) of MRMI. The role of therapists was to adjust appropriate dose at appropriate time following the Challenge Point Framework (CPF)¹² and base on clinical experience, individual circumstances and patient preferences as appropriate.^13,14

Knee–Ankle–Foot Orthoses: Intervention

Manual-assisted standing and walking training for dense stroke patients with lower limb paralysis are labour-intensive. Use of external support such as orthosis seems to be the easiest way to assist patients to try standing and walking, especially in the early stage of stroke. However, conventional gaiter, ankle foot orthosis (AFO) or air splint will only be able to support knee or ankle joint separately. Clinically meaningful improvement in functional mobility promoted active rehabilitation and facilitated quick recovery in patients with stroke by KAFO were reported.^{15,16,17,18,19,20,21} KAFO allowed patients to gain stability in paralyzed foot and walked with better dynamic balance.²¹ ASAP employed a set of KAFO (Gait Innovation (Dial Lock) + GS Double Klenzak) which was designed to be shared in the hospital with quickly and easily adjustable circumference of thigh cuff, heights of lower leg cuff, knee joint and thigh cuff by the lever and slides. A hold foot mechanism allowed subjects’ heels were held in the orthosis by tightening ankle belts. The insole and calf padding were custom-molded by the colleagues from Prosthetic and Orthotic Department. Physiotherapists would select suitable subjects for 5–10 sessions of mobility training with assistance by KAFO according inclusion criteria (premorbid MFAC above 3 and current MFAC from 1 to 3) and exclusion criteria (skin problem, increase tone, poor mental and medically unstable).

Robotic-Assisted Gait Training: Intervention

The RAGT was provided by a robot system device (Lokomat Pro; Hocoma Inc., Zurich, Switzerland) and operated by trained physiotherapists with Lokomat certification. The system for lower limb training was a motor-driven gait orthosis secured to the patient’s lower limbs. The patient’s whole body was supported by a body weight support system over a synchronised treadmill. The patients’ legs were guided on the treadmill according to a pre-programmed physiological gait pattern, which in combination with body weight support system, transmitted the treadmill movement to levers that induce the stance and swing phases. The system allowed specific level of guidance compatible to the patients’ clinical condition to achieve enhancement in gait speed, endurance and gait quality whilst minimising destructive compensatory gait pattern and avoidable stress to the patient. The physical stress of physiotherapy staff could also be reduced. The consistency and duration of training session could be ensured. Physiotherapist would select suitable subject, for 3–5 sessions per week, according the selection inclusion criteria of premorbid MFAC above 3 and current MFAC from 3 to 5; and exclusion criteria of skin problem, increase tone, poor mental and medically unstable. Each session lasted for 15–30 min depending on patients’ tolerance. The amount of bodyweight support was adjusted to maximise lower-extremity weight-bearing whilst ensuring correct stance and swing. The treadmill speed was set at a comfortable level that was specific to the patient, starting from 1.5 km/h (equal to 0.278 m/s) and was increased as tolerated. RGAT has been used in our department for stroke rehabilitation since 2014 and shown extra benefits to stroke patients in terms of ambulation, mobility and balance.²²

Demographic characteristics

Patient’s demographic and hospital information including age, gender, premorbid accommodation, stroke type, day since stroke, discharge destination and gym session were retrieved from the database of Physiotherapy Department of the Hospital and Clinical Management System of Hong Kong Hospital Authority. Gym session was the total number of physiotherapy gym session in the rehabilitation programme. The demographic characteristics and average functional outcomes of all subjects were demonstrated in number and percentage or mean and standard deviation.

Clinical outcomes

The primary clinical outcomes of the study were MRMI, Berg’s Balance Scale (BBS) and Modified Barthel Index (MBI). These functional scores of subjects derived admission MRMI, discharge MRMI, MRMI Gain, MRMI Efficiency; admission BBS, discharge BBS, BBS Gain, BBS Efficiency, admission MBI, discharge MBI, MBI Gain and MBI Efficiency. MRMI Gain was the difference between discharge MRMI and admission MRMI. MRMI Efficiency was the average gain in total MRMI ratings per gym session which was calculated by MRMI Gain divided by the number of gym session. The BBS Gain, BBS Efficiency, MBI Gain and MBI Efficiency were measured by same methods. The gain of a score indicated the overall effectiveness of rehabilitation programme and the efficiency of a score indicated the overall efficiency of rehabilitation programme.²³ Both gain and efficiency of scores were included to facilitate comparisons to other studies.

Modified Functional Ambulation Category

MFAC^24,25 was used to classify subjects walking capacity in this study. MFAC is a seven-point Likert Scale divided gait into seven categories (MFAC 1–MFAC 7), ranging from no ability to walk; and requires manual assistance to sit; or is unable to sit for 1 min without back or hand support (MFAC 1: Lyer) to the ability to walk independently on level and non-level surfaces, stairs and inclines (MFAC 7: Outdoor Walker).²⁴ The inter-rater reliability of the MFAC in term of intraclass correlation coefficient (ICC) was 0.982 (0.971–0.989), with a kappa coefficient of 0.923 and a consistency ratio of 94% for stroke patients.²⁶ Recent evidence also shows that MFAC could serve as a stratification tool of patients with stroke in inpatient rehabilitation.²³

Modified Rivermead Mobility Index

MRMI was used to assess subjects’ mobility in this study. The MRMI is highly reliable between raters ($\mathrm{\text{ICC}}=0.98$) and has high internal consistency (Cronbach’s $\mathrm{\text{alpha}}=0.93$) to early-stage patients with stroke. The MRMI consists of eight test items, including turning over, changing from lying to sitting, maintaining sitting balance, going from sitting to standing, standing, transferring, walking indoors and climbing stairs. The score of MRMI ranges from 0 to 40. One main characteristic of the MRMI is that subjects are scored by observation of their performance on the items directly.⁷

Berg’s Balance Scale

The BBS was used to assess patients’ balance in this study. The BBS has been shown to have excellent inter-rater ($\mathrm{\text{ICC}}=0.98$), intra-rater reliability ($\mathrm{\text{ICC}}=0.98$) and is internally consistent (0.96) to subjects with acute stroke.²⁷ BBS is shown to have 53% sensitivity to predict falls in elderly persons²⁸ and was able to detect changes in balance of patients with acute stroke.²⁹ The BBS is composed of 14 tasks. The scoring of each task is from 0 to 4. A score of 0 is given if the participant is unable to do the task, whilst a score of 4 is given if the participant is able to complete the task in accordance with the respective criterion. The total score of the BBS is 56.^27,30,31,32 The value of 45 points is used to calculate relative risk estimates which demonstrated predictive validity.²⁸ Hence, a score of 45 is shown to be an appropriate cutoff for safe and independent ambulation, and the need for assistive devices or supervision.³²

Modified Barthel Index

MBI was used to assess subjects’ basic activities of daily living (ADL) in this study. MBI measures the subject’s performance on ten functional items including self-care, continence and locomotion. The values assigned to each item are based on the amount of physical assistance required to perform the task and added to give a total score ranging from 0 to 100 ($0=\mathrm{\text{fully}}$ dependent, $100=\mathrm{\text{fully}}$ independent) with higher scores indicating higher levels of physical function.³³ There is no subtotal score because there is no sub-scale.³³ The internal consistency reliability coefficient for MBI is 0.90.³³

Statistical analysis

The between-group differences of patient characteristics were analysed by independent-sampled t-test or Chi-square. The within-group differences of admission MRMI and discharge MRMI; admission BBS and discharge BBS; as well as admission MBI and discharge MBI were analysed by paired t-test. The between-group differences of the characteristics including premorbid MFAC, admission MRMI, admission BBS, admission MBI, MRMI Gain, MRMI Efficiency, BBS Gain, BBS Efficiency, MBI Gain and MBI Efficiency were analysed by independent-sampled t-test. Results were considered statistically significant when $p<0.05$ and statistically highly significant when $p<0.001$. Data were analysed with the use of the SPSS v28.0.0.0 (190) statistical package (IBM SPSS Statistics).

Ethics statement

This study was performed in compliance with the principles of the Declaration of Helsinki to protect human subjects. The Joint Chinese University of Hong Kong–New Territories East Cluster Clinical Research Ethics Committee (The Joint CUHK-NTEC CREC) approval was obtained prior to commencement of the study. This trial design was registered prospectively with the ClinicalTrials.gov Protocol Registration and Results System (ClinicalTrials.gov ID: NCT05420103).

Baseline characteristics of subjects

There were totally 1,023 stroke patients screened for the study. In Pre-ASAP Period, 524 subjects received ASAP but 139 had no gym session, and amongst the remained 385 subjects, 29 transferred out, 7 DAMA and 1 died that 348 subjects were finally assigned to Pre-ASAP Group. On the other hand, in Post-ASAP Period, 499 subjects received ASAP but 166 had no gym session, and amongst the remained 333 subjects, 44 transferred out, 2 DAMA and 6 died that 281 subjects were assigned to Pre-ASAP Group (Fig.1). The baseline characteristics of subjects from Pre-ASAP Group and Post-ASAP Group are shown in Table1. The Pre-ASAP Group ($n=348$) consisted of 208 (59.8%) male, with the mean age of $71.76\pm 13.21$ and the mean day since stroke was $9.27\pm 8.01$. For the type of stroke, 73.6% was cerebral infract and 26.4% was cerebral hemorrhage. For the episode of stroke 77.0% was first stroke and 23.0% was recurrent stroke. The mean premorbid MFAC was $6.25\pm 1.38$; the mean admission MFAC was $2.77\pm 1.43$; the mean admission MRMI was $15.95\pm 9.90$; the mean admission BBS was $12.37\pm 14.82$ and the mean MBI was $40.55\pm 28.24$. The Post-ASAP Group ($n=281$) consisted of 137 (48.8%) male, with the mean age of $72.79\pm 13.22$ and the mean day since stroke was $9.90\pm 7.58$. For the type of stroke, 80.8% was cerebral infract and 19.2% was cerebral hemorrhage. For the episode of stroke, 80.1% was first stroke and 19.9% was recurrent stroke. The mean premorbid MFAC was $6.49\pm 1.12$; the mean admission MFAC was $2.87\pm 1.26$; the mean admission MRMI as $17.33\pm 9.14$; the mean admission BBS was $14.00\pm 14.88$ and the mean MBI was $46.86\pm 24.15$. All the baseline characteristics of subjects from both groups had no significant difference except the gender ($p=0.006$) and admission MBI ($p=0.003$) indicating that both groups were homogeneous except gender and admission basic ADL.

Programme content

The programme content of Pre-ASAP Group and Post-ASAP Group is shown in Table2. Both groups received traditional physiotherapy. Post-ASAP group had Stroke Registry, Reference MRMI Gain and Stroke Treatment Library. Post-ASAP group had mobility training with KAFO ($n=25$) but not in Pre-ASAP group ($n=0$). Both groups had mobility training with RAGT (Pre-ASAP Group, $n=14$; Post-ASAP Group, $n=26$). The mean number of gym session of both groups (Pre-ASAP Group was $12.30\pm 9.64$ sessions; Post-ASAP Group was $11.45\pm 9.83$ sessions) had no statistically significance ($p=0.168$).

Functional outcomes

The functional outcomes of Pre-ASAP Group and Post-ASAP Group are shown in Table3. Both groups had highly significant within-group improvement in MRMI, BBS and MBI ($p<0.001$). The MRMI Gain of Pre-ASAP Group and Post-ASAP Group was 6.32 and 7.42, respectively; and the difference was significant ($p<0.05$). The BBS Gain of Pre-ASAP Group and Post-ASAP Group was 8.17 and 9.70, respectively; and the difference was in margin of significance ($p=0.069$). The MBI Gain of Pre-ASAP Group and Post-ASAP Group was 10.69 and 11.96, respectively; but the difference was non-significant ($p=0.280$). The MRMI Efficiency, BBS Efficiency and MBI Efficiency of Post-ASAP Group ($0.93\pm 1.09$; $1.11\pm 2.09$; $1.42\pm 2.92$, respectively) were higher than those of Pre-ASAP Group ($0.75\pm 1.55$; $0.93\pm 1.89$; $1.15\pm 3.15$, respectively) but the difference was non-significant ($p=0.102$; $p=0.248$; $p=0.275$, respectively).

Table 3.

Functional outcomes of Pre-ASAP Group and Post-ASAP Group.

	Total ($n=629$)	Pre-ASAP ($n=348$)	Within group p	Post-ASAP ($n=281$)	Within group p	Between group p
Admission MRMI	16.57 (9.60)	15.95 (9.90)	$<0.001$**	17.33 (9.14)	$<0.001$**
Discharge MRMI	23.38 (10.33)	22.27 (10.68)		24.75 (9.72)
MRMI Gain	6.81 (6.26)	6.32 (6.48)		7.42 (5.94)		0.029*
MRMI Efficiency	0.35 (0.44)	0.75 (1.55)		0.93 (1.09)		0.102
Admission BBS	13.10 (14.85)	12.37 (14.82)	$<0.001$**	14.00 (14.88)	$<0.001$**
Discharge BBS	21.98 (17.47)	20.59 (17.47)		23.71(17.34)
BBS Gain	8.86 (10.48)	8.17 (10.46)		9.70 (10.46)		0.069
BBS Efficiency	1.01 (1.98)	0.93 (1.89)		1.11 (2.09)		0.248
Admission MBI	40.55 (28.24)	40.55 (28.24)	$<0.001$**	46.86 (24.15)	$<0.001$**
Discharge MBI	54.81 (27.58)	40.55 (28.24)		58.82 (23.91)
MBI Gain	11.29 (14.33)	10.69 (15.03)		11.96 (13.48)		0.280
MBI Efficiency	0.49 (0.76)	1.15 (3.15)		1.42 (2.92)		0.275

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Notes: *$p<0.05$, **$p<0.001$. Difference within group by paired t-test; difference between group by independent-sampled t-test. All functional outcomes were expressed as Mean (SD).

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