Effects of Cognitive Versus Task Oriented Training on Balance, Gait and Daily Activity in Chronic Stroke Patients

Not Applicable

Recruiting

• Conditions: Stroke, Ischemic; Cognitive Impairment; Balance; Distorted; ADL

• Registration Number: NCT06663657
• Lead Sponsor: Riphah International University

Brief Summary

To determine effects of cognitive sensorimotor exercises versus task oriented training on balance, gait and activities of daily living in chronic stroke patients.

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 Timeline

• Study Start: 2024-04-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-28
• Last Update Submitted: 2024-10-28
• Study First Posted: 2024-10-29
• Last Update Posted: 2024-10-29
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The BBS (Berg Balance Scale)	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).
The DGI (Dynamic Gait Index)	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,
The Modified Barthel Index	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.

Trial Locations

Locations (1)

Ripah Internationa University; 🇵🇰 Islamabad, Fedral, Pakistan