Home and Clinic Rehabilitation in Subacute Stroke (ADLS PAC HBP)

Background:

Stroke is the second leading cause of death and the third leading cause of long-term disability worldwide. The sub-acute phase of stroke, defined as 1 to 6 months following the stroke event, represents the most critical window for functional rehabilitation and neurological recovery. Physical therapy is a core component of stroke rehabilitation, focusing on helping people with stroke regain their ability to perform daily activities.

Common problems after stroke include weakness on one side of the body (hemiplegia), balance problems, difficulty walking, and reduced ability to perform daily activities. Approximately 15 to 30 out of 100 stroke survivors are left with lasting disabilities, and about 20 out of 100 require long-term care. More than half of people with stroke in the sub-acute phase are unable to walk independently.

Stroke rehabilitation has traditionally been provided in hospitals and rehabilitation centers. However, limited access to transportation, high costs of supervised rehabilitation, and shorter hospital stays have created a growing demand for home-based rehabilitation. Research has shown that structured home-based rehabilitation programs can significantly improve walking ability, balance, and daily activities in stroke survivors.

Despite this growing evidence, the comparative effectiveness of scheduled home-based rehabilitation versus clinic-based rehabilitation in the sub-acute phase remains unclear. There is a need for well-designed studies that directly compare these two approaches to guide rehabilitation planning and help healthcare systems use their resources effectively.

Objectives:

The primary objective of this study is to compare the effects of clinic-based rehabilitation and scheduled home-based rehabilitation on gait performance and functional capacity in people with sub-acute stroke.

Study Design:

This is a prospective, single-blinded randomized controlled trial. The study will be conducted at the University of Lahore Teaching Hospital, Lahore, Pakistan. The study duration is 9 months following synopsis approval.

Participants:

A total of 72 people with sub-acute stroke will be recruited and randomly placed into two equal groups of 36 participants each. This number includes a 20% dropout allowance. Participants must be aged 40 to 50 years, male or female, with a confirmed stroke diagnosis between 3 to 6 months prior to joining the study.

Inclusion Criteria:

• Age 40 to 50 years
• Male and female
• Stroke confirmed between 3 to 6 months prior to enrollment
• Able to understand and follow instructions
• Grade 1+ spasticity on Modified Ashworth Scale
• Modified Rankin Scale score of 3 to 4
• Able to maintain sitting balance for at least 1 hour

Exclusion Criteria:

• Myocardial infarction
• Other neurological conditions causing disability
• Contractures
• Severe difficulty speaking or severe cognitive impairment
• Need for further surgery or medical care

Randomization and Blinding:

Participants will be randomly placed into treatment groups using the envelope concealment method. This is a single-blinded study in which the person measuring outcomes does not know which group each participant belongs to.

Interventions:

Group A - Clinic-based Rehabilitation (Control Group):**

Participants will attend hospital-based physiotherapy sessions on alternate days, 3 days per week, for 60 minutes per session over 12 weeks. The treatment program includes:

Gait Training:

• Weight shifting: stand with feet hip-width apart, shift weight side to side, hold 3 seconds per side, 2 sets of 10 repetitions
• Stepping drills: forward and side stepping, 2 sets of 10 repetitions each direction
• Assisted walking practice: walk 10 to 20 meters with walker, focusing on even step length and heel-to-toe motion, 10 to 15 minutes

Lower Limb Coordination:

• Heel-to-shin exercise: 10 repetitions per leg, 2 sets
• Alternate leg extensions: hold 2 to 3 seconds, 10 to 15 repetitions per leg, 2 to 3 sets
• Obstacle step-overs: 10 to 12 repetitions per leg
• Ball kicking: 10 to 15 times each leg

Balance and Mobility Tasks:

• Heel raises: 10 to 15 repetitions, 2 to 3 sets
• Toe walking: 10 to 20 steps, 2 to 3 sets
• Sit-to-stand: 10 to 12 repetitions, 2 to 3 sets
• Walking drills: 3 to 5 rounds focusing on heel-to-toe motion

Group B - Clinic-based plus Scheduled Home-based Rehabilitation (Experimental Group):**

Participants will receive the same clinic-based physiotherapy program as Group A. In addition, they will perform a structured home exercise program on non-clinic days, tracked using a weekly logbook. The home program includes:

• Supported marching: lift one knee at a time while holding walker, 10 to 20 repetitions per leg
• Step-up training: step up with weaker leg first, 10 repetitions per leg, 2 sets
• Sit-to-stand: 10 repetitions using walker for support
• Partial squats: sit on firm chair, lean forward slightly with straight back, hold for 10 minutes
• Balance and coordination exercises: weight shifting, single leg standing, and heel-to-toe walking while holding a chair, 10 repetitions each

**Outcome Measures:**

Data will be collected at baseline and after 12 weeks of intervention.

Primary Outcome Measures:

1. Timed Up and Go Test (TUG): measures walking ability, balance, and mobility. The participant stands up from a chair, walks 3 meters, turns around, walks back, and sits down. The time taken is recorded in seconds. A longer time indicates poorer mobility.
2. Lawton-Brody Instrumental Activities of Daily Living Scale (IADL): measures the ability to perform daily activities including telephone use, shopping, food preparation, housekeeping, laundry, transportation, medication management, and financial management. Scores range from 0 (fully dependent) to 8 (fully independent) for women and 0 to 5 for men.

Data Analysis:

Data will be analyzed using SPSS version 25. Results for measurable variables will be shown as mean plus or minus standard deviation. Results for descriptive variables will be shown as frequency and percentage. Normality will be checked using the Kolmogorov-Smirnov test. For normally distributed data, repeated measures ANOVA will be used for within-group analysis and independent samples t-test for between-group analysis. If data are not normally distributed, the Mann-Whitney U test and Wilcoxon signed-rank test will be used. A confidence interval of 95% and a p-value of 0.05 or less will be considered statistically significant.

Ethical Considerations:

This study has been approved by the Institute Research Ethics Board (IREB) of the Faculty of Allied Health Sciences, University of Lahore. The study will be conducted in accordance with the Declaration of Helsinki guidelines. Written informed consent will be obtained from all participants in both English and Urdu. All participant information will be kept strictly confidential. Participation is entirely voluntary and participants may withdraw at any time without any effect on their care.