Robotic Rehabilitation and Dual-Task Exercises in Hemiplegic Patients

NCT06709222 | Not Yet Recruiting

• 1 other identifier: Uskudar17
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Coping; Hemiplegia

Outcome Measures

Primary Outcomes (3)

• Timed up and go test

  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.

  14 weeks

• Improvement on Montreal Cognitive Assessment test of 5 points or more than baseline( total score is out of 30 points)

  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.

  14 weeks

• Mini-Mental State Examination

  Mini-Mental State Examination, 1 point for each correct answer maximun score: 30 - minimum score:24

  14 weeks

Study Arms (2)

control

ACTIVE COMPARATOR

the group that received robotic rehabilitation only

Other: robotic rehabilitation

exercise

EXPERIMENTAL

group receiving robotic rehabilitation and dual-task exercises

Other: robotic rehabilitation; Other: exercise

Interventions

robotic rehabilitation OTHER

robotic rehabilitation

control; exercise

exercise OTHER

dual-task exercises

exercise

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Literacy

You may not qualify if:

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

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (1)

Sancak Medical Center

Istanbul, Sancaktepe, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 38745227 BACKGROUND

• 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.

  PMID: 38703695 BACKGROUND

• 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.

  PMID: 37777679 BACKGROUND

MeSH Terms

Conditions

Hemiplegia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kübra UZUN

  Uskudar University

  STUDY CHAIR

Central Study Contacts

Ömer ŞEVGİN

CONTACT

+905069787535; omer.sevgin@uskudar.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr.

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: December 13, 2025
• Primary Completion: March 20, 2026
• Study Completion: March 30, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)