Clinical trial NCT06709222: Robotic Rehabilitation and Dual-Task Exercises in Hemiplegic Patients
Official title: Investigation of the Effectiveness of Dual-Task Exercises Applied in Addition to Robotic Rehabilitation in Hemiplegic Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Coping
Hemiplegia
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Berg balance scale
timeFrame: 14 weeks
measure: Timed up and go test
timeFrame: 14 weeks
measure: Improvement on Montreal Cognitive Assessment test of 5 points or more than baseline( total score is out of 30 points)
timeFrame: 14 weeks
measure: Mini-Mental State Examination
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sancak Medical Center
state: Sancaktepe
Study officials:
affiliation: Uskudar University
name: Esra Çal
role: STUDY_CHAIR
References:
citation: Li Y, Lian Y, Chen X, Zhang H, Xu G, Duan H, Xie X, Li Z. Effect of task-oriented training assisted by force feedback hand rehabilitation robot on finger grasping function in stroke patients with hemiplegia: a randomised controlled trial. J Neuroeng Rehabil. 2024 May 14;21(1):77. doi: 10.1186/s12984-024-01372-3.
citation: Ye JY, Chen R, Chu H, Lin HC, Liu D, Jen HJ, Banda KJ, Kustanti CY, Chou KR. Dual-task training in older adults with cognitive impairment: A meta-analysis and trial sequential analysis of randomized controlled trials. Int J Nurs Stud. 2024 Jul;155:104776. doi: 10.1016/j.ijnurstu.2024.104776. Epub 2024 Apr 18.
citation: Uysal I, Ozden F, Tumturk I, Imerci A. The effectiveness of dual task exercise training on balance, mobility, physical performance, and quality of life in children with cerebral palsy: a single-blind randomized controlled trial. Ir J Med Sci. 2024 Apr;193(2):813-821. doi: 10.1007/s11845-023-03530-3. Epub 2023 Sep 30.