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NCT Number: NCT06709222

Robotic Rehabilitation and Dual-Task Exercises in Hemiplegic Patients

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

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Key information

Conditions

Cognitive Coping Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sancak Medical Center

Istanbul, Sancaktepe, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • Literacy

Exclusion criteria

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

Treatment and study plan

Robotic Rehabilitation

Other

robotic rehabilitation

Exercise

Other

dual-task exercises

Primary outcomes

  1. 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.

  2. 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.

  3. Mini-Mental State Examination

    Time frame: 14 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ömer ŞEVGİN

CONTACT

[email protected]

+905069787535

Sponsors and collaborators

Lead sponsor

Uskudar University

Other

Registry information

Official study title

Investigation of the Effectiveness of Dual-Task Exercises Applied in Addition to Robotic Rehabilitation in Hemiplegic Patients: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 29, 2024
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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