Effects of Unilateral Versus Bilateral Task Specific Training With Visual Feedback in Post Stroke Patients

May 4, 2026 updated by: Riphah International University

Effects of Unilateral Versus Bilateral Task Specific Training With Visual Feedback on Lower Limb on Balance, Gait and Sensation in Post Stroke Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Stroke is a neurological deficit due to vascular lesion. It occur due to blood flow obstruction and by the rupture of blood vessels. It causes neurological damage such as weakness, numbness, impaired balance, gait and loss of proprioception. These impairment lead to decrease mobility, increase risk of fall and reduce the quality of life. Task specific training focus on repetitive practice with meaningful, goal directed task to facilitate motor relearning. Visual feedback promote motor recovery and brain plasticity. Task specific training with visual feedback has been shown to enhance motor relearning and sensory integration. However most rehabilitation program focus only the affected limb. The aim of this study is to determine effects of unilateral versus bilateral task specific training with visual feedback on lower limb on balance, gait and sensation in post stroke patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Lahore, Pakistan, 54000
        • Department of Physical Therapy, Sahet Medical complex Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 10 meter walk test (0.4-0.8m/s)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: bilateral task specific training with visual feedback
Other: bilateral task specific training with visual feedback on lower limb
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
Experimental: unilateral task specific training with visual feedback
Other: unilateral task specific training with visual feedback on lower limb
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Berg Balance Scale
Time Frame: 6 weeks

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)
Time Frame: 6 weeks
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
Time Frame: 06 weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zain Ul Abbas, Ms, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR & AHS/25/0223

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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