Robot-assisted Exercise in Patients With Amputation Using Myoelectric Prosthesis

Study Overview
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Brief Summary
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The aim of this study was to investigate the effect of a robot-assisted biofeedback exercise program on grip strength, movement speed, coordination, functional status, depressive status, and quality of life in patients with a myoelectric prosthesis with upper limb amputation. In the literature review, There is no robot-assisted exercise program applied in patients using upper extremity myoelectric prosthesis. The expected benefit from this study is to show that the functional status, depressive status, and quality of life of the patients who received robot-assisted biofeedback exercise were better than those who had a home exercise program only.

Detailed Description
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The study was planned as a randomized prospective clinical study. The study was planned to include 16 patients. New amputation patients will be excluded from the study. The patients in the study group will have 5 sessions of exercise in the hospital for a week. The control group will receive a home exercise program. Statistical analysis Student t-test will be used for the comparison of descriptive statistical methods (mean, standard deviation, median, frequency, and ratio) and normal distribution parameters between groups. Pearson chi-square test, Yates Continuity Correction, Fisher-Freeman-Halton Exact Test, Fisher Exact Test, and Marginal Homogeneity Test will be used to compare qualitative data. The results will be evaluated at 95 % confidence interval and p <0.01 and p <0.05.

Official Title
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Efficacy of Robot-assisted Exercise Program in Patients With Upper Limb Amputation Using Myoelectric Prosthesis

Conditions
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Prosthesis User, Amputation

Intervention / Treatment
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* Device: Robot
* Other: Home exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Upper elbow amputation Being using myoelectric prosthesis for amputated upper extremity Be literate To be able to complete and complete the tests at the level of mental and physical activity Being 18-65 years old Exclusion Criteria: Patients with neurological sequelae Patients who could not cooperate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Treatment group: robot-assisted exercise program Control: Home exercise program
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: robot-assisted exercise<br>Robot-assisted exercise program will applied by patients with upper limb amputation using myoelectric prosthesis | Device: Robot<br>* Patients with upper limb amputation using myoelectric prosthesis will done robot-assisted exercise program<br>|
| Active Comparator: Home exercise<br>Home exercise program will applied by patients with upper limb amputation using myoelectric prosthesis | Other: Home exercise<br>* Patients with upper limb amputation using myoelectric prosthesis will done home exercise program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinematic data | range of motion (ROM): unit is degree | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amputation, robotic rehabilitation, Prosthesis