NCT07576153

Brief Summary

This study will be a single blinded randomized controlled trail. Non probability convenience sampling will be used to recruit the patients of either gender, aged 40-65 years, patients with the subacute phase (\>3months post stroke) and able to follow the instructions. This study will be carried out in Gulab Devi Hospital and Sahet Medical Complex Lahore. These participants will be randomly allocated to Group A will receive bilateral task specific training with visual feedback, whereas Group B will receive unilateral task specific training with visual feedback. Both group will perform their respective exercises 40 minutes, five days a week for 6weeks. The Participants will be evaluated at the start and end of the exercise program through Berg Balance scale to assess balance, 10 Meter Walk Test to assess gait and Fugl Meyer Assessment of lower extremity to assess sensation. Data will be analyzed by SPSS version 27.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
2mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Jul 2025Jul 2026

Study Start

First participant enrolled

July 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

May 4, 2026

Last Update Submit

May 4, 2026

Conditions

Keywords

SensationGaitBalanceVisual feedback,Task specific training,Bilateral and Unilateral training,Stroke rehabilitation,

Outcome Measures

Primary Outcomes (3)

  • Berg Balance Scale

    Berg balance (BBG) is a widely used clinical test to assess a person's static and dynamic balance abilities. It consist of 14 performance based tasks each scored on a 5 point scale from 0 to 4 for a maximum total score of 56. It used for individuals with balance impairments such as post stroke patients. In scoring criteria 4 score perform task independently and safely, 3 score perform with supervision or slight assistance, 2 score perform with moderate assistance or deviation, 1score perform with major assistance and 0 score unable to perform The scoring range 41-56 low risk balance impairment, 21-40 moderate risk balance impairment and 0-20 high risk balance impairment Test retest (ICC =0.96; 95% CI, 0.93-0.98) and inter-rater (ICC=0.93; 95% CI, 0.87=0.97) reliability was excellent

    6 weeks

  • Meter Walk Test (TMWT)

    10 meter walk test is use to assess the gait and gait speed over a short distance. It is an important predictor of functional independence, fall risk and community mobility. It is perform by the patient to walk a total 14 meter at a comfortable speed, only the middle 10 meter are timed to eliminate acceleration and deceleration bias. First 2 meter acceleration, middle 10 meter time walking and last 2 meter deceleration. Repeat the test twice. The Scoring of 10 meter walk test have predicted values, gait speed \< 0.4 m/ s functional status (household ambulation), 0.4 - 0.8 m/s limited community ambulation, \> 0.8 m/s community ambulation and \> 1.2 m/s safe for crossing the street

    6 weeks

  • Fugl- Meyer Assessment - Lower Extremity

    Fugl Meyer Assessment Lower Extremity is widely used outcome tool to measure in rehabilitation, particularly for stroke patients. To measure the sensation, it include light touch sensation and proprioception. The scoring criteria each item is on a 3 point scale; 0 unable to perform the task, 1 impaired and 2 normal. The total score ranges from 0 to 10. Light touch 2 sites and 2 points total score 4. Proprioception 3 joints 2 points total score 6

    06 weeks

Study Arms (2)

bilateral task specific training with visual feedback

EXPERIMENTAL
Other: bilateral task specific training with visual feedback on lower limb

unilateral task specific training with visual feedback

EXPERIMENTAL
Other: unilateral task specific training with visual feedback on lower limb

Interventions

The group will received bilateral task specific training along with visual feedback on lower limb. Bilateral training is used in rehabilitation to promote functional recovery of impaired limbs by engaging both affected and non-affected sides. Task specific training include weight shifting, sit to stand, stepping forward / lateral and bilateral walking over uneven surfaces. Visual feedback will be given by mirrors and visual targets place on the floor. Visual feedback helping patients to improve balance and body awareness, particularly for individuals with sensory or motor impairments following a stroke. Bilateral task specific training with visual feedback will perform for five days per week for six weeks. The participants in this group underwent 40 minutes of bilateral lower limb training. Pre and post intervention values will be recorded to assess the effectiveness

bilateral task specific training with visual feedback

This group received unilateral task specific training with visual feedback on affected limb. Task specific training include weight shifting, seated marching, stepping forward / lateral, and walk on uneven surface. Unilateral task specific training with visual feedback will perform for five days per week for six weeks. The participants in this group underwent 40 minutes of unilateral lower limb training. Pre and post intervention values will be recorded to assess the effectiveness.

unilateral task specific training with visual feedback

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40-65 years
  • Both gender male and female
  • Pre diagnose with the Stroke
  • Patient with a subacute phase (\>3months post stroke)
  • Ability to understand and follow the instructions (8)
  • Berg Balance Scale (BBS) score between 21-40
  • meter walk test (0.4-0.8m/s)

You may not qualify if:

  • Severe cognitive Impairment
  • Visual and vestibular Impairment
  • Other orthopedic or neurological disorder
  • unilateral neglect

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy, Sahet Medical complex Lahore

Lahore, 54000, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Zain Ul Abbas, Ms

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 8, 2026

Study Start

July 1, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations