- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06663657
Effects of Cognitive Versus Task Oriented Training on Balance, Gait and Daily Activity in Chronic Stroke Patients
Effects of Cognitive Sensorimotor Exercises Versus Task Oriented Training on Balance ,Gait and Activities of Daily Living in Chronic Stroke Patients.
Study Overview
Status
Intervention / Treatment
Detailed Description
This study will be randomized clinical trial with total of 40 participants with chronic stroke. Patients will be recruited from Riphah rehabilitation centre and National Hospital Lahore. The sampling technique will be non probability convenience sampling technique. The patients will be randomized by lottery method and allocated into two intervention groups.
Patients in group A will receive cognitive sensorimotor exercises for 30 minutes, sessions for 5 days per week for 8 weeks. Patients in group B will receive task-oriented training for 30 minutes, sessions for 5 days per week for 8 weeks. Intervention will be applied for 8 weeks it includes taking reading 1st at baseline, 2nd reading at 4th week and 3rd reading at 8th week and follow up after 12 weeks. The assessment tools used will be berg balance test for balance, Dynamic gait index for gait and Modified Barthel index to assess activities of daily livings. Data will be analysed by using SPSS 25 version.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Fedral
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Islamabad, Fedral, Pakistan, 44000
- Ripah Internationa University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients diagnosed with chronic stroke (6 months to 2 years)
- Patients with the ability to walk independently using aids or orthotics with or without supervision.
- Ability to communicate and follow instructions.
- No problem walking due to ankle contracture.
- No sensory deficiencies of the lower extremities.
- Patients cognition level on MMSE ≥ 24
Exclusion Criteria:
- Recent injuries- Patients having musculoskeletal or surgical problems of lower extremity.
- Co-morbid conditions- Cardiovascular (uncontrolled high blood pressure, diabetes), respiratory problems like dyspnoea.
- Neurological conditions- like brain tumour, demyelinating disease, Parkinson's disease, multiple sclerosis).
- Subjects with auditory and vestibular disorders.
- Cerebellar related problems.
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: cognitive sensorimotor exercise group
Patients in group A will receive cognitive sensorimotor exercises for 30 minutes, sessions for 5 days per week for 8 weeks.
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Patients in group A will receive cognitive sensorimotor exercises for 30 minutes, sessions for 5 days per week for 8 weeks.
|
|
Active Comparator: Task based training group
Patients in group B will receive task oriented training for 30 minutes, sessions for 5 days per week for 8 weeks.
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Patients in group B will receive task oriented training for 30 minutes, sessions for 5 days per week for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The BBS (Berg Balance Scale)
Time Frame: 10 months
|
The BBS (Berg Balance Scale) comprises 14 items aimed at evaluating balance function in older adults residing in the community.
Each item is scored on a 5-point scale, ranging from 0 to 4, with a total score range of 0 to 56.
Higher scores indicate better balance function.
The scale exhibits robust psychometric properties, including good internal consistency (Cronbach's α = 0.92-0.98),
strong interrater reliability (interclass correlation coefficient = 0.97), and favorable concurrent validity (high correlations [r = 0.91-0.95]
with the PASS and the Static Balance Test).
|
10 months
|
|
The DGI (Dynamic Gait Index)
Time Frame: 10 months
|
The DGI (Dynamic Gait Index) is an eight-item assessment tool designed to evaluate balance, functional mobility, and gait.
Notably, the evaluation setting lacked stairs, prompting subjective patient reporting for the stair climbing item to facilitate completion of the measure.
Importantly, research supports that omitting the stair component does not compromise the validity or integrity of the DGI.
Each of the eight DGI items is scored on a 4-point scale, where a score of 3 indicates no gait dysfunction, 2 reflects minimal dysfunction, 1 represents moderate dysfunction, and 0 denotes severe dysfunction.
The total maximum score achievable is 24.
The test can be administered in approximately 10 minutes,
|
10 months
|
|
The Modified Barthel Index
Time Frame: 10 months
|
The Modified Barthel Index is a 100-point scale used to assess a patient's proficiency in performing 10 types of Activities of Daily Living (ADL).
Each ADL is assigned a numeric value based on the level of assistance the patient requires.
Lower scores on the MBI suggest decreased independence, while higher scores indicate greater self-sufficiency.
A perfect score of 100 signifies complete independence in basic ADL, whereas the minimum score of 0 indicates total dependence on assistance for these activities.
The MBI provides a quantitative measure of an individual's functional status in daily tasks, aiding in the evaluation of their overall independence.
|
10 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: zeest Z hashmi, MSNMPT, Riphah International University
Publications and helpful links
General Publications
- Kim KH, Jang SH. Effects of Cognitive Sensory Motor Training on Lower Extremity Muscle Strength and Balance in Post Stroke Patients: A Randomized Controlled Study. Clin Pract. 2021 Sep 14;11(3):640-649. doi: 10.3390/clinpract11030079.
- Sutcu G, Ozcakar L, Yalcin AI, Kilinc M. BOBATH vs. TASK-ORIENTED TRAINING AFTER STROKE: An assessor-blind randomized controlled trial. Brain Inj. 2023 Jun 7;37(7):581-587. doi: 10.1080/02699052.2023.2203519. Epub 2023 Apr 19.
- Ghrouz A, Guillen-Sola A, Morgado-Perez A, Munoz-Redondo E, Ramirez-Fuentes C, Curbelo Pena Y, Duarte E. The effect of a motor relearning on balance and postural control in patients after stroke: An open-label randomized controlled trial. Eur Stroke J. 2024 Jun;9(2):303-311. doi: 10.1177/23969873231220218. Epub 2023 Dec 29.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/24/0201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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