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Clinical Trials/NCT04353622
NCT04353622
Completed
N/A

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

Marmara University1 site in 1 country24 target enrollmentFebruary 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Marmara University
Enrollment
24
Locations
1
Primary Endpoint
Modified Ashworth Scale
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
May 15, 2019
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

iremakgun

Physiotherapist

Marmara University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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).

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.

Secondary Outcomes

  • Nottingham Extended Activities of Daily Living Scale(before treatment and at six weeks of the beginning of the treatment)
  • Upper Extremity Motor Activity Log(before treatment and at six weeks of the beginning of the treatment)

Study Sites (1)

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