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

Stroke Clinical Trial

Official title:

Is Robot-Assisted System Effective for the Maximization of Upper Extremity Motor Recovery in Intensive Body Rehabilitation Following a Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05559385
• Other study ID #: 09.2021.168
• Status: Completed
• Phase: N/A
• Start date: January 2, 2022
• Est. completion date: August 5, 2022

Study information

• Verified date: September 2022
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 5, 2022
• Est. primary completion date: June 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Robot-Assissted Therapy
Houston Bionics ExoRehab X brand/model device was used for improving the upper extremity in subacute stroke.

Procedure:
• Conventional Rehabilitation
It is an upper extremity rehabilitation program prepared in line with individual needs.

Locations

Country	Name	City	State
Turkey	Marmara University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Emresenocak

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the baseline
Primary	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.	At the end of the 6th week
Secondary	Demographic Data Form	Demographic Characteristics	At the baseline
Secondary	- 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.	At the baseline
Secondary	- 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.	At the end of the 6th week
Secondary	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.	At the baseline
Secondary	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.	At the end of the 6th week