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Is Robot-Assisted Therapy Effective for the Upper Extremity Following a Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Robot-Assissted Therapy
Conventional Rehabilitation
Sponsored by
Emresenocak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Robotic Rehabilitation, Conventional Rehabilitation, Intensıve Trunk Rehabilitation, Motor Function

Eligibility Criteria

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

Inclusion Criteria:

  • Age 40-85 years and having had a stroke in the last six months,
  • Mini-Mental State Assessment score >20,
  • Able to sit safely,
  • No neglect issue,
  • Fugl-Meyer Upper Extremity Assessment score <58.

Exclusion Criteria:

  • Modified Ashworth Scale >2,
  • Severe reduction in visual acuity,
  • Participation in another rehabilitation program,
  • Subluxation or pain in the shoulder region.

Sites / Locations

  • Marmara University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic Rehabilitation Group

Conventional Rehabilitation Group

Arm Description

The standardized ITR program was applied to both groups for 60 minutes a day, five days a week, for six weeks. The ITR program included exercises of abdominal strengthening, controlled pelvic movements, bridging, trunk lateral flexion and rotation, reaching forward, and push-ups with a Swiss Ball. This group received a robotic rehabilitation program for the upper extremity with a Houston Bionics ExoRehab X brand/model device. This device has no motor force of repulsion or attraction. Patients initiate and maintain their movements during the exercise. The device supports the patient's active movement and allows extensive movement repetition. Before starting robotic rehabilitation, the patient was seated upright on the platform. The games were projected onto a 43-inch television screen. The exercise program was planned to include upper extremity movements in all directions.

The standardized ITR program was applied to both groups for 60 minutes a day, five days a week, for six weeks. During this period, lower extremity rehabilitation was added if needed in addition to trunk rehabilitation. Exercises for the lower extremities were applied according to the patient's individual needs. The ITR program included exercises of abdominal strengthening, controlled pelvic movements, bridging, trunk lateral flexion and rotation, reaching forward and sideways, and push-ups with a Swiss Ball. CR applied after the ITR program consisted of an individualized rehabilitation program for the upper extremities. These rehabilitation programs generally included activities for functional purposes (dressing, object manipulation, reaching, cup holding, range of motion, strengthening, weight-bearing, etc.). The treatment program was applied five days a week for six weeks, with the session duration limited to 60 minutes.

Outcomes

Primary Outcome Measures

Fugl-Meyer Upper Extremity Assessment:
This disease-specific scale was created as an objective motor impairment scale to assess recovery in post-stroke hemiplegic patients. It includes subsections that assess joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score that can be obtained is 66, with a high score indicating good motor condition.
Fugl-Meyer Upper Extremity Assessment:
This disease-specific scale was created as an objective motor impairment scale to assess recovery in post-stroke hemiplegic patients. It includes subsections that assess joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score that can be obtained is 66, with a high score indicating good motor condition.

Secondary Outcome Measures

Demographic Data Form
Demographic Characteristics
- Wolf Motor Function Test:
This test was created to evaluate the motor ability of the upper extremity. The test consists of 17 items, 15 of which are related to the fields of functional skill and performance time, and 2 to muscle strength (20). The two items of muscle strength evaluation were not used in this study. A high score indicates fine motor ability.
- Wolf Motor Function Test:
This test was created to evaluate the motor ability of the upper extremity. The test consists of 17 items, 15 of which are related to the fields of functional skill and performance time, and 2 to muscle strength (20). The two items of muscle strength evaluation were not used in this study. A high score indicates fine motor ability.
Trunk Impairment Scale
This scale evaluates static and dynamic sitting balance, and trunk coordination with seventeen items. The total score ranges from 0 - 23 points, with a higher score indicating better performance.
Trunk Impairment Scale
This scale evaluates static and dynamic sitting balance, and trunk coordination with seventeen items. The total score ranges from 0 - 23 points, with a higher score indicating better performance.

Full Information

First Posted
September 25, 2022
Last Updated
September 29, 2022
Sponsor
Emresenocak
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1. Study Identification

Unique Protocol Identification Number
NCT05559385
Brief Title
Is Robot-Assisted Therapy Effective for the Upper Extremity Following a Stroke
Official Title
Is Robot-Assisted System Effective for the Maximization of Upper Extremity Motor Recovery in Intensive Body Rehabilitation Following a Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 2, 2022 (Actual)
Primary Completion Date
June 17, 2022 (Actual)
Study Completion Date
August 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emresenocak

4. Oversight

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

5. Study Description

Brief Summary
The aim of this study was to investigate the effects on upper-limb motor function of the addition of robotic rehabilitation (RR) and conventional rehabilitation (CR) treatments to intensive trunk rehabilitation (ITR). A total of 41 subacute stroke patients were randomly allocated to two groups: RR and CR. Both groups received the same ITR procedure (6x5x60 weeks/days/minutes). Following ITR, a robot-assisted rehabilitation program of 60 minutes, five days a week, for six weeks, was applied to the RR group, and an individualized upper extremity rehabilitation program to the CR group. Evaluations were made at baseline and after six weeks using the Trunk Impairment Scale (TIS), Fugl-Meyer Upper Extremity Motor Evaluation Scale (FMA-UE), and Wolf Motor Function Test (WMFT).
Detailed Description
Assessments: - Demographic Data Form: The researchers created a form to include the information on age, gender, stroke onset date, lesion type, affected side, and dominant extremity. - Fugl-Meyer Upper Extremity Assessment: This disease-specific scale was created as an objective motor impairment scale to assess recovery in post-stroke hemiplegic patients (18). It includes subsections that assess joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score that can be obtained is 66, with a high score indicating good motor condition. The affected upper extremities are assessed with the subject in a seated position. - Wolf Motor Function Test: This test was created to evaluate the motor ability of the upper extremity (19). The test consists of 17 items, 15 of which are related to the fields of functional skill and performance time, and 2 to muscle strength (20). The total score is used for the functional ability of the patients. The two items of muscle strength evaluation were not used in this study. - Trunk Impairment Scale: This scale evaluates static and dynamic sitting balance and trunk coordination with seventeen items. The total score ranges from 0 - 23 points, with a higher score indicating better performance. The test-retest and inter-rater reliability coefficients of the scale have been shown to be 0.85-0.99 (21).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Robotic Rehabilitation, Conventional Rehabilitation, Intensıve Trunk Rehabilitation, Motor Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Randomized Controlled (One group received Robotic Rehabilitation, other group received conventional rehabilitation)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robotic Rehabilitation Group
Arm Type
Experimental
Arm Description
The standardized ITR program was applied to both groups for 60 minutes a day, five days a week, for six weeks. The ITR program included exercises of abdominal strengthening, controlled pelvic movements, bridging, trunk lateral flexion and rotation, reaching forward, and push-ups with a Swiss Ball. This group received a robotic rehabilitation program for the upper extremity with a Houston Bionics ExoRehab X brand/model device. This device has no motor force of repulsion or attraction. Patients initiate and maintain their movements during the exercise. The device supports the patient's active movement and allows extensive movement repetition. Before starting robotic rehabilitation, the patient was seated upright on the platform. The games were projected onto a 43-inch television screen. The exercise program was planned to include upper extremity movements in all directions.
Arm Title
Conventional Rehabilitation Group
Arm Type
Active Comparator
Arm Description
The standardized ITR program was applied to both groups for 60 minutes a day, five days a week, for six weeks. During this period, lower extremity rehabilitation was added if needed in addition to trunk rehabilitation. Exercises for the lower extremities were applied according to the patient's individual needs. The ITR program included exercises of abdominal strengthening, controlled pelvic movements, bridging, trunk lateral flexion and rotation, reaching forward and sideways, and push-ups with a Swiss Ball. CR applied after the ITR program consisted of an individualized rehabilitation program for the upper extremities. These rehabilitation programs generally included activities for functional purposes (dressing, object manipulation, reaching, cup holding, range of motion, strengthening, weight-bearing, etc.). The treatment program was applied five days a week for six weeks, with the session duration limited to 60 minutes.
Intervention Type
Device
Intervention Name(s)
Robot-Assissted Therapy
Intervention Description
Houston Bionics ExoRehab X brand/model device was used for improving the upper extremity in subacute stroke.
Intervention Type
Procedure
Intervention Name(s)
Conventional Rehabilitation
Intervention Description
It is an upper extremity rehabilitation program prepared in line with individual needs.
Primary Outcome Measure Information:
Title
Fugl-Meyer Upper Extremity Assessment:
Description
This disease-specific scale was created as an objective motor impairment scale to assess recovery in post-stroke hemiplegic patients. It includes subsections that assess joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score that can be obtained is 66, with a high score indicating good motor condition.
Time Frame
At the baseline
Title
Fugl-Meyer Upper Extremity Assessment:
Description
This disease-specific scale was created as an objective motor impairment scale to assess recovery in post-stroke hemiplegic patients. It includes subsections that assess joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score that can be obtained is 66, with a high score indicating good motor condition.
Time Frame
At the end of the 6th week
Secondary Outcome Measure Information:
Title
Demographic Data Form
Description
Demographic Characteristics
Time Frame
At the baseline
Title
- Wolf Motor Function Test:
Description
This test was created to evaluate the motor ability of the upper extremity. The test consists of 17 items, 15 of which are related to the fields of functional skill and performance time, and 2 to muscle strength (20). The two items of muscle strength evaluation were not used in this study. A high score indicates fine motor ability.
Time Frame
At the baseline
Title
- Wolf Motor Function Test:
Description
This test was created to evaluate the motor ability of the upper extremity. The test consists of 17 items, 15 of which are related to the fields of functional skill and performance time, and 2 to muscle strength (20). The two items of muscle strength evaluation were not used in this study. A high score indicates fine motor ability.
Time Frame
At the end of the 6th week
Title
Trunk Impairment Scale
Description
This scale evaluates static and dynamic sitting balance, and trunk coordination with seventeen items. The total score ranges from 0 - 23 points, with a higher score indicating better performance.
Time Frame
At the baseline
Title
Trunk Impairment Scale
Description
This scale evaluates static and dynamic sitting balance, and trunk coordination with seventeen items. The total score ranges from 0 - 23 points, with a higher score indicating better performance.
Time Frame
At the end of the 6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 40-85 years and having had a stroke in the last six months, Mini-Mental State Assessment score >20, Able to sit safely, No neglect issue, Fugl-Meyer Upper Extremity Assessment score <58. Exclusion Criteria: Modified Ashworth Scale >2, Severe reduction in visual acuity, Participation in another rehabilitation program, Subluxation or pain in the shoulder region.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aysel Yildiz Ozer, PhD
Organizational Affiliation
Marmara University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Adem Aktürk, PhD
Organizational Affiliation
Gelişim University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elif Korkut, PhD
Organizational Affiliation
Bağcılar Education and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara University
City
Istanbul
ZIP/Postal Code
34083
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Is Robot-Assisted Therapy Effective for the Upper Extremity Following a Stroke

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