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

NCT06663657 | Completed DMC

• 1 other identifier: REC/RCR & AHS/24/0201
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic; Cognitive Impairment; Balance; Distorted; ADL

Keywords

Stroke, Ischemic; Cognitive Impairment; Balance; Distorted; ADL

Outcome Measures

Primary Outcomes (3)

• The BBS (Berg Balance Scale)

  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)

  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

  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

Study Arms (2)

cognitive sensorimotor exercise group

EXPERIMENTAL

Patients in group A will receive cognitive sensorimotor exercises for 30 minutes, sessions for 5 days per week for 8 weeks.

Other: Cognitive Sensorimotor Exercises

Task based training group

ACTIVE COMPARATOR

Patients in group B will receive task oriented training for 30 minutes, sessions for 5 days per week for 8 weeks.

Other: Task Oriented Training group

Interventions

Cognitive Sensorimotor Exercises OTHER

Patients in group A will receive cognitive sensorimotor exercises for 30 minutes, sessions for 5 days per week for 8 weeks.

cognitive sensorimotor exercise group

Task Oriented Training group OTHER

Patients in group B will receive task oriented training for 30 minutes, sessions for 5 days per week for 8 weeks.

Task based training group

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Ripah Internationa University

Islamabad, Fedral, 44000, Pakistan

Location

Related Publications (3)

• 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.

  PMID: 34563008 BACKGROUND

• 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.

  PMID: 37074234 BACKGROUND

• 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.

  PMID: 38158722 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• zeest Z hashmi, MSNMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 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 include taking reading 1st at baseline, 2nd reading at 4th week and 3rd reading at 8th week and follow up after 12 weeks

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 29, 2024
• Study Start: April 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 15, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)