Exoskeleton-assisted Upper Limb Rehabilitation After Stroke

October 18, 2023 updated by: iremakgun, Marmara University

Exoskeleton-assisted Upper Limb Rehabilitation After Stroke: A Randomized Controlled Trial

In recent studies, it has been observed that robotic devices make a positive contribution to motor recovery and the activities of daily living. However, studies about the effects of stroke rehabilitation with robotic devices are limited.

This study aimed to investigate the effect of upper extremity robotic rehabilitation on motor function and quality of life in stroke patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Stroke survivors have difficulties in participating in activities of daily living due to functional disabilities. The majority of patients after stroke need rehabilitation to gain independence in daily life as the first target. Therefore, different treatment approaches are used in stroke rehabilitation.

The use of technology in stroke rehabilitation has become very common in recent years. Robotic devices used in rehabilitation enhance the healing process by giving patients more intensive and task-oriented exercises. A lot of systematic and meta-analysis studies have shown that robot-assisted devices provide positive motor recoveries, especially in the treatment of upper extremities. However, the optimal timing, duration, and dose of robotic rehabilitation that should be applied after stroke remain uncertain.

In the light of this information, this study examines the effects of the robotic device produced for upper limb rehabilitation on daily life activities and motor function.

Study Type

Interventional

Enrollment (Actual)

24

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 Locations

  • Turkey
      • Istanbul, Turkey
        • Marmara University Faculty of Health Sciences

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

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having ischemic or hemorrhagic stroke history
  • Being at the age between 40 and 85
  • MAS (Modified Ashworth Scale) < 3 for upper extremity
  • At least 6 months after stroke
  • Participants who agree to participate in the study

Exclusion Criteria:

  • Cardiovascular weakness (severe hypertension, coronary artery disease)
  • Mini-Mental State Examination score < 24
  • Recurrent stroke
  • Having other orthopedic and neurologic conditions that may affect upper extremity movement
  • Having behavioral and cognitive problems

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Robot-assisted Treatment
Rehabilitation protocol was applied with robotic device (HOUSTONBIONİCS ExoRehab UE1).
Device: Exoskeleton robot for upper extremity

Robot-assisted Treatment Program:

  • 10 minutes elbow flexion/extension
  • 10 minutes forearm supination/pronation
  • 10 minutes wrist flexion/extension
  • 10 minutes ulnar/radial deviation

Frequency: 2/week Duration: 12 sessions (6 weeks)
Active Comparator: Conventional Physiotherapy
Conventional physiotherapy program included neurophysiological approaches.
Other: Conventional physiotherapy
Ferquency: 2/week Duration: 12 sessions (6weeks) Each session: 50 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Upper Extremity Assessment
Time Frame: before treatment and at six weeks of the beginning of the treatment
Fugl-Meyer Upper Extremity Assessment is an index to assess physical performance in individuals who had a stroke. This index consists of 33 items. Each item scored between 0 and 2. The highest score for the upper extremity is 66.
before treatment and at six weeks of the beginning of the treatment
Modified Ashworth Scale
Time Frame: before treatment and at six weeks of the beginning of the treatment
Modified Ashworth Scale is used for measuring the spasticity of upper extremity skeletal muscle. The Modified Ashworth Scale (MAS) is scored from 0 to 5 to measure the resistance encountered when performing passive muscle stretching. The lowest score is 0 (no spasticity) and the highest score is 5 (severe spasticity).
before treatment and at six weeks of the beginning of the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper Extremity Motor Activity Log
Time Frame: before treatment and at six weeks of the beginning of the treatment
Upper Extremity Motor Activity Log consists of two subscales (amount of use and quality of movement) that determine how often the patient uses the affected side in daily life activities and how successful this activity is. Items on each scale are scored between 0 and 5.
before treatment and at six weeks of the beginning of the treatment
Nottingham Extended Activities of Daily Living Scale
Time Frame: before treatment and at six weeks of the beginning of the treatment
Nottingham Extended Activities of Daily Living Scale is designed for stroke patients but can be also used for other diseases. The scale has 22 items divided into 4 areas of daily life. These areas are mobility, kitchen, domestic and leisure activities. Each item scored between 0 and 3. The highest score of scale is 66.
before treatment and at six weeks of the beginning of the treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini-Mental State Examination
Time Frame: Before treatment
Mini-Mental State Examination is used to determine the cognitive level. This scale consists of 11 items. The highest score is 30. 24 and higher scores are considered normal.
Before treatment

Collaborators and Investigators

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

Sponsor

Marmara University

Investigators

  • Principal Investigator: İrem Akgün, Marmara University

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 (Actual)

February 1, 2019

Primary Completion (Actual)

May 15, 2019

Study Completion (Actual)

May 15, 2019

Study Registration Dates

First Submitted

February 21, 2020

First Submitted That Met QC Criteria

April 16, 2020

First Posted (Actual)

April 20, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2019.146

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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