NCT04030585

Robot-assisted Exercise in Patients With Amputation Using Myoelectric Prosthesis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Prosthesis User
• Amputation

Interventions

Type	Name	Description
DEVICE	Robot	Patients with upper limb amputation using myoelectric prosthesis will done robot-assisted exercise program
OTHER	Home exercise	Patients with upper limb amputation using myoelectric prosthesis will done home exercise program

Timeline

• Start date: 2019-07-24
• Primary completion: 2021-11-13
• Completion: 2021-11-13
• First posted: 2019-07-24
• Last updated: 2021-12-17

Locations

1 site across 1 country: Turkey (Türkiye)