NCT07613554

Brief Summary

The goal of this clinical trial is to learn if adding scheduled home-based rehabilitation to clinic-based rehabilitation improves walking ability and daily activities in people aged 40 to 50 with sub-acute stroke. The main questions it aims to answer are:

  • Does adding home exercises improve walking ability in people with sub-acute stroke?
  • Does adding home exercises improve the ability to do daily activities in people with sub-acute stroke? Researchers will compare clinic-based rehabilitation plus home-based rehabilitation to clinic-based rehabilitation alone to see if adding home exercises leads to better recovery after stroke. Participants will:
  • Attend physical therapy at the hospital 3 days per week for 12 weeks
  • Do walking practice, balance training, and leg exercises at the clinic
  • Do home exercises including marching, step-ups, sit-to-stand, and balance exercises on non-clinic days (home exercise group only)
  • Track home exercises using a weekly logbook
  • Be tested at the start and after 12 weeks

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Jun 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Jun 2026Mar 2027

First Submitted

Initial submission to the registry

May 21, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

May 21, 2026

Last Update Submit

May 21, 2026

Conditions

Keywords

stroke rehabilitationsub-acute strokehome-based rehabilitationclinical-based rehabilitationfunctional capacitybalancegait trainingtimed up and go testHemiplegiaActivities of daily living

Outcome Measures

Primary Outcomes (2)

  • Timed Up and Go Test (TUG)

    Assesses functional mobility, balance, and gait performance. The patient stands up from a chair, walks 3 meters, turns, walks back and sits down. Time is recorded in seconds. Higher time indicates poorer mobility.

    Baseline and 12 weeks

  • Lawton-Brody Instrumental Activities of Daily Living Scale (IADL)

    Assesses functional performance in daily living 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."

    Baseline and 12 weeks

Study Arms (2)

Group A: Clinic-based Rehabilitation

ACTIVE COMPARATOR

Patients will receive clinic-based physiotherapy sessions three days per week, 60 minutes per session, over 12 weeks. Treatment includes gait training, lower limb coordination exercises, and balance and mobility tasks.

Behavioral: Physical Therapy Rehabilitation Program

Group B: Clinic-based plus Home-based Rehabilitation

EXPERIMENTAL

Patients will receive the same clinic-based physiotherapy program as Group A plus a structured scheduled home exercise program performed on remaining days, tracked via a weekly logbook over 12 weeks.

Behavioral: Physical Therapy Rehabilitation Program

Interventions

A structured physical therapy program including gait training, lower limb coordination, balance and mobility tasks for clinic sessions, and home exercises including supported marching, step-ups, sit-to-stand, partial squats, and balance exercises.

Also known as: Home-based Rehabilitation Program
Group A: Clinic-based RehabilitationGroup B: Clinic-based plus Home-based Rehabilitation

Eligibility Criteria

Age40 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 40-50 years old Male and female Patients having stroke 3 months to 6 months prior to enrollment Able to comprehend and adhere to instructions Grade 1+ spasticity on Modified Ashworth Scale Modified Rankin Scale score of 3-4 with ability to maintain sitting balance for at least 1 hour

You may not qualify if:

  • Myocardial infarction Other neurological deficits leading to disability Contractures Severe dysphasia and cognitive impairment Need for further surgery or medical care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This is a single-blinded study. Only the outcomes assessor is blinded to group allocation. Blinding of participants and care providers was not possible due to the nature of the physical therapy interventions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two parallel groups: Group A receiving clinic-based rehabilitation and Group B receiving clinic-based rehabilitation plus scheduled home-based rehabilitation, over 12 weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2026

First Posted

May 29, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

May 29, 2026

Record last verified: 2026-05