Robotic Rehabilitation and Dual-Task Exercises in Hemiplegic Patients

July 16, 2025 updated by: Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Sancaktepe
      • Istanbul, Sancaktepe, Turkey
        • Sancak Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control
the group that received robotic rehabilitation only
Other: robotic rehabilitation
robotic rehabilitation
Experimental: exercise
group receiving robotic rehabilitation and dual-task exercises
Other: robotic rehabilitation
robotic rehabilitation
Other: exercise
dual-task exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 weeks
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.
14 weeks
Mini-Mental State Examination
Time Frame: 14 weeks
Mini-Mental State Examination, 1 point for each correct answer maximun score: 30 - minimum score:24
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uskudar University

Investigators

  • Study Chair: Kübra UZUN, Uskudar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 13, 2025

Primary Completion (Estimated)

March 20, 2026

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

November 25, 2024

First Submitted That Met QC Criteria

November 27, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Actual)

July 20, 2025

Last Update Submitted That Met QC Criteria

July 16, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uskudar17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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