Robot-assisted Exercise in Patients With Amputation Using Myoelectric Prosthesis

Not Applicable

Completed

• Conditions: Amputation; Prosthesis User
• Interventions: Other: Home exercise; Device: Robot

• Registration Number: NCT04030585
• Lead Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-07-22
• Study First Submitted QC: 2019-07-22
• Study Start: 2019-07-24
• Study First Posted: 2019-07-24
• Primary Completion: 2021-11-13
• Study Completion: 2021-11-13
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-16
• Last Update Posted: 2021-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home exercise	Home exercise	Home exercise program will applied by patients with upper limb amputation using myoelectric prosthesis
robot-assisted exercise	Robot	Robot-assisted exercise program will applied by patients with upper limb amputation using myoelectric prosthesis

Primary Outcome Measures

Name	Time	Method
Kinematic data	1 day	range of motion (ROM): unit is degree

Trial Locations

Locations (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital; 🇹🇷 İstanbul, Turkey