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Clinical Trials/NCT05559385
NCT05559385
Completed
N/A

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

Emresenocak1 site in 1 country41 target enrollmentJanuary 2, 2022
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Emresenocak
Enrollment
41
Locations
1
Primary Endpoint
Fugl-Meyer Upper Extremity Assessment:
Status
Completed
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 2, 2022
End Date
August 5, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Emresenocak
Responsible Party
Sponsor Investigator
Principal Investigator

Emresenocak

Research Assisstant

Marmara University

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.

Outcomes

Primary Outcomes

Fugl-Meyer Upper Extremity Assessment:

Time Frame: At the end of the 6th week

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 Outcomes

  • Trunk Impairment Scale(At the end of the 6th week)
  • Demographic Data Form(At the baseline)
  • - Wolf Motor Function Test:(At the end of the 6th week)

Study Sites (1)

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