NCT07328867

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 14, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2025

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
Last Updated

January 9, 2026

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

December 29, 2025

Last Update Submit

December 29, 2025

Conditions

Keywords

Physical therapyStrokePerturbation Based TrainingDual-Task TrainingBalanceCognitionFall risk

Outcome Measures

Primary Outcomes (2)

  • Balance

    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

    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 Outcomes (1)

  • Fall Risk

    6 Weeks

Study Arms (2)

Dual-task and Perturbation Based Training

EXPERIMENTAL

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

Perturbation Based Training

ACTIVE COMPARATOR

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

Interventions

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.

Dual-task and 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.

Perturbation Based Training

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2025

First Posted

January 9, 2026

Study Start

June 14, 2025

Primary Completion

September 26, 2025

Study Completion

December 10, 2025

Last Updated

January 9, 2026

Record last verified: 2025-12

Locations