Robot-assisted Exercise in Patients With Amputation Using Myoelectric Prosthesis

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Status: Completed

Conditions: Amputation; Prosthesis User

Treatments: Device: Robot; Other: Home exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04030585

MYO-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

robot-assisted exercise

Experimental group

Description:

Robot-assisted exercise program will applied by patients with upper limb amputation using myoelectric prosthesis

Treatment:

Device: Robot

Home exercise

Active Comparator group

Description:

Home exercise program will applied by patients with upper limb amputation using myoelectric prosthesis

Treatment:

Other: Home exercise