Investigation of the Effectiveness of Dual-Task Exercises Applied in Addition to Robotic Rehabilitation in Hemiplegic Patients: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Timed up and go test
Study Overview
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 40 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 6 weeks. The exercises will be explained to the patients in detail one-on-one and repeated.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Diagnosis of post-stroke hemiplegia (hemiplegia onset must be between 3 months and 1 year).
- •Age range: 30-60 years.
- •Voluntariness to participate in rehabilitation.
- •Patients with a motor function loss of 30-70% according to Fugl-Meyer Motor Assessment results.
Exclusion Criteria
- •History of active psychiatric disease.
- •Severe joint deformities or other neurological diseases.
- •Having had a recent stroke during rehabilitation.
Outcomes
Primary Outcomes
Timed up and go test
Time Frame: 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)
Time Frame: 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
Time Frame: 14 weeks
Mini-Mental State Examination, 1 point for each correct answer maximun score: 30 - minimum score:24
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr. Öğr. Üyesi Ömer Şevgin
Asst. Prof. Dr.
Uskudar University