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Exoskeleton-assisted Upper Limb Rehabilitation After Stroke

Primary Purpose

Stroke, Upper Extremity Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exoskeleton robot for upper extremity
Conventional physiotherapy
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Upper extremity, Robotic rehabilitation, Motor function, Quality of life

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Marmara University Faculty of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Robot-assisted Treatment

Conventional Physiotherapy

Arm Description

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

Conventional physiotherapy program included neurophysiological approaches.

Outcomes

Primary Outcome Measures

Fugl-Meyer Upper Extremity Assessment
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.
Modified Ashworth Scale
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).

Secondary Outcome Measures

Upper Extremity Motor Activity Log
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.
Nottingham Extended Activities of Daily Living Scale
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.

Full Information

First Posted
February 21, 2020
Last Updated
October 18, 2023
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT04353622
Brief Title
Exoskeleton-assisted Upper Limb Rehabilitation After Stroke
Official Title
Exoskeleton-assisted Upper Limb Rehabilitation After Stroke: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
May 15, 2019 (Actual)
Study Completion Date
May 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Upper Extremity Dysfunction
Keywords
Stroke, Upper extremity, Robotic rehabilitation, Motor function, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robot-assisted Treatment
Arm Type
Active Comparator
Arm Description
Rehabilitation protocol was applied with robotic device (HOUSTONBIONİCS ExoRehab UE1).
Arm Title
Conventional Physiotherapy
Arm Type
Active Comparator
Arm Description
Conventional physiotherapy program included neurophysiological approaches.
Intervention Type
Device
Intervention Name(s)
Exoskeleton robot for upper extremity
Intervention Description
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
Other
Intervention Name(s)
Conventional physiotherapy
Intervention Description
Ferquency: 2/week Duration: 12 sessions (6weeks) Each session: 50 minutes
Primary Outcome Measure Information:
Title
Fugl-Meyer Upper Extremity Assessment
Description
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.
Time Frame
before treatment and at six weeks of the beginning of the treatment
Title
Modified Ashworth Scale
Description
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).
Time Frame
before treatment and at six weeks of the beginning of the treatment
Secondary Outcome Measure Information:
Title
Upper Extremity Motor Activity Log
Description
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.
Time Frame
before treatment and at six weeks of the beginning of the treatment
Title
Nottingham Extended Activities of Daily Living Scale
Description
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.
Time Frame
before treatment and at six weeks of the beginning of the treatment
Other Pre-specified Outcome Measures:
Title
Mini-Mental State Examination
Description
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.
Time Frame
Before treatment

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İrem Akgün
Organizational Affiliation
Marmara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara University Faculty of Health Sciences
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

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Exoskeleton-assisted Upper Limb Rehabilitation After Stroke

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