Robotic Rehabilitation and Dual-Task Exercises in Hemiplegic Patients

Not Applicable

Recruiting

• Conditions: Cognitive Coping; Hemiplegia

• Registration Number: NCT06709222
• Lead Sponsor: Uskudar University

Brief Summary

The aim of this study was to investigate the effectiveness of dual-task exercises combined with robotic rehabilitation applied to post-stroke hemiplegia patients.

Detailed Description

This research is designed as a randomized controlled experimental study. The study will be conducted on 50 hemiplegic patients. Participants will be randomly divided into two groups. Patients in the exercise group will be subjected to dual-task exercises together with robotic rehabilitation. Patients in the control group will be subjected to only the robotic rehabilitation treatment program. Both groups will be treated with 30-45 minute sessions, 3 days a week for 12 weeks. The exercises will be explained to the patients in detail one-on-one and repeated.

Study Timeline

• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-27
• Study First Posted: 2024-11-29
• Status Verified: 2024-12
• Study Start: 2024-12-13
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18
• Primary Completion: 2025-03-20
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Diagnosis of post-stroke hemiplegia (hemiplegia onset must be between 3 months and 1 year).
• Age range: 45-65 years.
• Voluntariness to participate in rehabilitation.
• Patients with a motor function loss of 30-70% according to Fugl-Meyer Motor Assessment results.
• Literacy

Exclusion Criteria

• History of active psychiatric disease.
• Severe joint deformities or other neurological diseases.
• Having had a recent stroke during rehabilitation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Berg balance scale	14 weeks	Berg balance scale (BBS) is used for assessment of balance and fall risk, Higher scores on the BBS indicate greater independence and better ability to balance. In contrast, lower scores indicate a greater fall risk Items DESCRIPTION SCORE (0-4) Sitting to standing _____ Standing unsupported _____ Sitting unsupported _____ Standing to sitting _____ Transfers _____ Standing with eyes closed _____ Standing with feet together _____ Reaching forward with outstretched arm _____ Retrieving object from floor _____ Turning to look behind _____ Turning 360 degrees _____ Placing alternate foot on stool _____ Standing with one foot in front _____ Standing on one foot _____ TOTAL __/56
Timed up and go test	14 weeks	Timed up and go test is used for the assessment of falls risk among elderly population. The Timed "Up and Go" (TUG) Test measures, in seconds, the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down.; Normal healthy elderly usually complete the task in 10 seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more.; Clinical guide: \<10 seconds = normal \<20 seconds = good mobility, can go out alone, mobile without a gait aid \<30 seconds = problems, cannot go outside alone, requires a gait aid A score of more than or equal to 14 seconds has been shown to indicate high risk of falls.
Improvement on Montreal Cognitive Assessment test of 5 points or more than baseline( total score is out of 30 points)	14 weeks	Subject will complete 3 Montreal Cognitive assessment prior to study over 1 week time. Best score of three is used.; After study is complete subject will also undergo 3 Montreal cognitive assessment over 1 week immediately after study. Again best score is used.
Mini-Mental State Examination	14 weeks	Mini-Mental State Examination, 1 point for each correct answer maximun score: 30 - minimum score:24

Trial Locations

Locations (1)

Sancak Medical Center; 🇹🇷 Istanbul, Sancaktepe, Turkey