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Clinical Trials/NCT05601115
NCT05601115
Completed
Not Applicable

The Effect of Combined Robotic Hand Therapy and Conventional Therapy to Rehabilitation Outcomes in Stroke Patients

Afyonkarahisar Health Sciences University1 site in 1 country50 target enrollmentDecember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Afyonkarahisar Health Sciences University
Enrollment
50
Locations
1
Primary Endpoint
ABILHAND Stroke Hand Function Questionnaire
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

RAT is an innovative approach that includes intensive, repeatable, interactive and personalized applications.The aim of tihis study is to investigate the effect of robotic hand therapy added to conventional rehabilitation on rehabilitation outcomes in stroke patients.

Detailed Description

Effective therapy in stroke rehabilitation should include repetitive, functional and task-specific exercises with high intensity and duration. In this context, in addition to traditional treatments, many new treatment approaches have come up in recent years. Robot-assisted therapy (RAT) is one of these new treatment approaches. RAT is an innovative approach that includes intensive, repeatable, interactive and personalized applications. It is seen that robotic systems are very suitable for the patient to receive more intense and task-oriented motor training by integrating with other rehabilitation approaches. Considering the scarcity of studies on robotic hand therapy, it was seen that larger scale and long-term studies are needed. In this study, investigators aimed to investigate the effect of robotic hand therapy added to conventional rehabilitation on motor functions and quality of life in stroke patients. Patients will be evaluated pretreatment, posttreatment and 3 months later after treatment. Evaluation parameters consist of Brunnstrom Staging, Modified Ashworth Scale (MAS), Fugl Meyer Assessment of The Upper Extremity, Functional Independence Measure Scale (FIM) and ABILHAND Questionnaire, Stroke Impact Scale (SIS), Stroke-Specific Quality of Life Scale (SS-QOL) and SF-36 Quality of Life Questionnaire. We think that robot-assisted therapy will contribute to the improvement of hand functions and quality of life in stroke patients.

Registry
clinicaltrials.gov
Start Date
December 1, 2021
End Date
June 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Afyonkarahisar Health Sciences University
Responsible Party
Principal Investigator
Principal Investigator

Sevda Adar

assistant professor

Afyonkarahisar Health Sciences University

Eligibility Criteria

Inclusion Criteria

  • Unilateral stroke
  • Between 4 weeks and 6 months after stroke
  • health status was suitable for rehabilitation
  • who could understand commands with a mini mental test score of 15 and above
  • who had Brunnstrom grade 3 and below (≤3).

Exclusion Criteria

  • Patients with persistent upper extremity pain on the hemiplegic side (VAS\>40)
  • Patients with severe spasticity in the hand (MAS≥3)
  • Patients with contractures in the hand
  • Patients who had fractures or operations on the hemiplegic side in the last 6 months
  • Patients who received botulinum toxin injection to the upper extremity in the last 6 months
  • Patients with skin ulcers
  • Patients with brain stem or cerebellar lesions
  • Patients with neglect or apraxia
  • Patients with severe visual impairment and severe depression

Outcomes

Primary Outcomes

ABILHAND Stroke Hand Function Questionnaire

Time Frame: 15 minutes

The ABILHAND Hand Questionnaire was developed in 1998 to measure patient-perceived dexterity. It contains 23 questions about how difficult the patient has to do the activities. impossible (0 points), difficult (1 point), easly (2 points) options is marked. The total score is 46.

upper extremity spasticity assessment

Time Frame: 5 minutes

It was planned to evaluate spasticity with the Modified Ashworth Scale (MAS). In MAS, patients are evaluated over 5 points. 0; there is no increase in muscle tone, and 4 indicates that the extremity is rigid in the direction of flexion and extension.

Brunnstrom stage

Time Frame: 5 minutes

Brunnstrom Staging is a test that evaluates the motor development of hemiplegic patients. In this test, the neurophysiological recovery process of the hemiplegic patient was defined as 6 stages. According to this staging low stage; stage 1 (flask, the stage without voluntary movement), the highest stage was determined as stage 6 (stage with isolated joint movement). Hand, upper and lower limbs in Brunnstrom staging extremities are evaluated separately.

Fugl Meyer Upper Extremity Assessment Questionnaire wrist and hand assessment

Time Frame: 15 minutes

The Fugl-Meyer Upper Extremity Motor Rating Scale was developed to quantitatively evaluate sensorimotor recovery after stroke.Based on Brunnstrom's stages of motor recovery

Secondary Outcomes

  • Functional Independence Scale(20 minutes)
  • Stroke Specific Quality of Life Scale: SSQOL(30 minutes)
  • short form 36(30 minutes)
  • Stroke Impact Survey(20 minutes)

Study Sites (1)

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