Combined Effects of Dual-task and Perturbation Based Training on Balance and Cognition in Stroke Patients

December 29, 2025 updated by: Foundation University Islamabad
This study aims to evaluate the Combined Effects of Dual-task and Perturbation Baesd Training on Balance and Cognition in Stroke Patients. Stroke is an acute cerebrovascular disorder that can impair cognitive, motor, and balanace abilites. Stroke is the second largest cause of death and disability globally. According tp studies, people who have had a stroke are more likely to fall than others who are same age and gender. PBBT is known as artificially induced balance training technique that can mimics the loss of balance that can occur naturally in freal life. Reduction in falls has been reported broadly by the use of perturbation based balance training. Current study will be and RCT on 33 participants based on the inclusion critieria. Participants will be randomly and equally divided into two groups; group B receiving Perturbation Based Training Alone and Group A receiving Dual-task and Perturbation Based Balance Training. The treatment will be given for 40 minutes, 3 days a week for 6 consecutive weeks. The assessment will be conducted at baseline, for cognition by Montreal Cognitive Assessment Scale (MoCA), for initial treadmill speed 10 Meter Walk Test (10MWT), for balance by Berg Balance Scale (BBS), and for fall riak by Fall Efficacy Scale (FES). Final assessment will be conducted after 6 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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 multifaceted disease that can be caused by a variety of risk factors, disease processes and causes. Stroke results in the change of cognitive function, which effects resulting in minor impairment to the development of post-stroke dementia. The cognitive deficiencies in a stroke survivors have significant influence on their daily productivity. In addition, falls are a prevalent and potentially fatal issue for as many as 47% of all stroke patients admitted to the hospital.Some studies suggest that Dual-task training when paired with mechanical action of treadmill could maximize the constraint on the cognitive control processes for gait.

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 (Actual)

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.
33

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
      • Islamabad, Pakistan, 44000
        • Foundation University College of Physical Therapy

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:

  • No limitation of genders.
  • Age between 25-80 years
  • Participants diagnosed with chronic stroke
  • Participants being able to walk with or without walking aid independently or under supervision
  • Participants with impaired balance as indicated by a score of <=41 on BBS
  • Participants with Montreal Cognitive Assessment Score <26

Exclusion Criteria:

  • Patient with sinificant co morbidties or secondary complications including orthopedic or rheumatological disorders were excluded
  • Patients with severe cognitive impairment or dementia
  • Apraxia or hemi-neglect
  • Participants with body weight >100kg
  • Participants with significant visual or hearing impairments
  • Patients with epilepsy or pacemaker
  • Participants with peripheral or central neuropathies that could impair balance

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: None (Open Label)

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: Dual-task and Perturbation Based Training
  1. Participants in the experimental group received combined perturbation and dual task training
  2. The intervention was conducted for 3 days a week for 6 consecutive weeks
  3. Each treatment session lasted approximately 40 minutes including 5 minute of warmup and 2 minutes of rest between 2 segments
  4. Primary training modality was treadmill
  5. Initial walking speed was determined individually for each participant by using 10MWT
  6. Perturbations were applied manually during treadmill walking
  7. The intensity of treadmill was progressively increased across sessions by change in directions of perturbations, unpredictability, walking speed and reducing hand support when safe
  8. Dual-task training is added after 3 session and will be performed concurrently with perturbation training.
  9. Cognitive tasks include counting backwards, naming animals, subtracting 3 from 100.
  10. The complexity of the task will progressively increased
  11. Safety should be ensured by using the harness
Procedure: Perturbation + Dual-Task Training

The intervention program spans six weeks and involves both supervised Perturbation sessions and Dual-Task training exercises. Participants will attend three supervised Perturbation based training per week, with each session consisting of two 8-minute segments of the training.

In addition, participants will perform Dual-Task training and perturbations on treadmill, with each cycle consisting of two segments. This combination of supervised practice will be increased progressively throughout all six weeks. Across the entire program, participants will complete a total of 18 supervised perturbation based balance training and 18 Dual-task training sessions.
Active Comparator: Perturbation Based Training
  1. Participants in control group received Perturbation Baesd Training Alone
  2. The intervention was conducted for 3 days a week for 6 consecutive weeks
  3. Each treatment session lasted 40 minutes including 5 minute of warm up and 2 minute of rest between segments
  4. Primary training modality was treadmill
  5. Initial walking speed was determined individually for each participant by using 10MWT
  6. Perturbations were appllied manually during treadmill walking
  7. The intensity of treadmill was progressively increased across sessions by chanfe in directions of perturbations, unpredictability, walking speed and reducing hand support when safe
  8. Safety should be ensured by using the harness, keeping emergency stop at reach, and use of handrails when necessary
Procedure: Perturbation-Based Training
The control group will participate in a structured six-week intervention program consisting exclusively of the Perturbation Based Balance Training. Participants will attend three supervised sessions per week, ensuring consistent oversight and proper technique throughout the program. Each session will began with a warm-up period, followed by two 8-minute segments of perturbation-based treadmill training, with participants allowed a rest period of 60 second to 2 minute between repetitions to prevent fatigue and maintain the quality of each movement. The frequency is maintained consistently, however, perturbations dosage was progressively increased across all six weeks to provide a standardized exposure, allowing for accurate comparison with other intervention groups. Over the entire six-week period, participants will complete a total of 18 supervised sessions, each with three repetitions, summing up to 108 bouts across the intervention.

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
Balance
Time Frame: 6 weeks
Berg Balance Scale (BBS) was used, Maximum Total=56 points (41-56=Low fall risk, 21-40= Medium fall risk, 0-20 High fall risk)
6 weeks
Cognition
Time Frame: 6 weeks
Montreal Cognitive Assessment Scale, Maximum score=30 (26-30= normal cognition, 18-25= mild cognitive impairment, 10-17 moderate cognitive Impairment, <10=severe cognitive impairment
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fall Risk
Time Frame: 6 Weeks
Fall Efficacy Scale (FES), Total score=10-100 (higher score = greater fear of falling
6 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.
Foundation University Islamabad

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.
June 14, 2025

Primary Completion (Actual)

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.
September 26, 2025

Study Completion (Actual)

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.
December 10, 2025

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).
December 29, 2025

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.
December 29, 2025

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.
January 9, 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.
January 9, 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.
December 29, 2025

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.
December 1, 2025

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.
  • FUI/CTR/2025/16

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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