- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07328867
Combined Effects of Dual-task and Perturbation Based Training on Balance and Cognition in Stroke Patients
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Islamabad, Pakistan, 44000
- Foundation University College of Physical Therapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Dual-task and Perturbation Based 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
|
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
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/CTR/2025/16
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Stroke
-
National Assembly ClinicBayero University Kano, NigeriaRecruitingStroke | Stroke Hemorrhagic | Stroke Ischemic | Hemiparesis After StrokeNigeria
-
University of PittsburghRecruitingHemorrhagic Stroke | Embolic Stroke of Undetermined Source | Ischemic Stroke, Cryptogenic | Recurrent Ischemic Stroke | Ischemic Stroke, EmbolicUnited States
-
Mahidol UniversityNot yet recruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke SurvivorsThailand
-
Mahidol UniversityRecruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke PatientThailand
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
Fondazione Don Carlo Gnocchi OnlusScuola Superiore Sant'Anna di Pisa; Fondazione Policlinico Universitario Campus...Not yet recruitingStroke | Stroke Hemorrhagic | Upper Limb Rehabilitation | Stroke IschemicItaly
-
Samsung Medical CenterCompletedChronic Stroke | Subacute Stroke | ExoskeletonSouth Korea
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
Clinical Trials on Perturbation + Dual-Task Training
-
University of Illinois at ChicagoNational Institute on Aging (NIA); Roybal Predoctoral pilot grantRecruitingMild Cognitive Impairment | Old Age; DebilityUnited States
-
Sezen Karaborklu ArgutRecruitingPostural Balance | Healthy Older Adults | Dual Task Exercises in Elderly People | Dual Task CostTurkey (Türkiye)
-
Foundation University IslamabadCompletedCognitive Dysfunction | Cognitive Decline | Diabetic Neuropathy | BalancePakistan
-
Hacettepe UniversityGazi University; Saglik Bilimleri UniversitesiCompletedWalking | Cognition | Parkinson's Disease (PD) | Mobility | Balance | Dual-taskTurkey (Türkiye)
-
Riphah International UniversityCompletedIntellectual DisabilityPakistan
-
Riphah International UniversityCompleted
-
University of LahoreCompletedStroke | Hemiplegia | Hemiplegia Following Ischemic StrokePakistan
-
Universitas PadjadjaranNot yet recruitingStroke, CerebrovascularIndonesia
-
Eastern Mediterranean UniversityCompletedMild Cognitive ImpairmentCyprus
-
King Saud UniversityCompletedStroke | Chronic Stroke | Middle Cerebral Artery StrokeSaudi Arabia