Exoskeleton-assisted Upper Limb Rehabilitation After Stroke

NCT ID: NCT04353622

Last Updated: 2023-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-05-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke Upper Extremity Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Robot-assisted Treatment

Rehabilitation protocol was applied with robotic device (HOUSTONBIONİCS ExoRehab UE1).

Group Type ACTIVE_COMPARATOR

Exoskeleton robot for upper extremity

Intervention Type DEVICE

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)

Conventional Physiotherapy

Conventional physiotherapy program included neurophysiological approaches.

Group Type ACTIVE_COMPARATOR

Conventional physiotherapy

Intervention Type OTHER

Ferquency: 2/week Duration: 12 sessions (6weeks) Each session: 50 minutes

Interventions

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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)

Intervention Type DEVICE

Conventional physiotherapy

Ferquency: 2/week Duration: 12 sessions (6weeks) Each session: 50 minutes

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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iremakgun

Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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İrem Akgün

Role: PRINCIPAL_INVESTIGATOR

Marmara University

Locations

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Marmara University Faculty of Health Sciences

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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09.2019.146

Identifier Type: -

Identifier Source: org_study_id

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