Robot-assisted Exercise in Patients With Amputation Using Myoelectric Prosthesis

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.

Completed

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Key information

Conditions

Prosthesis User Amputation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, 34192, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robot

Device

Patients with upper limb amputation using myoelectric prosthesis will done robot-assisted exercise program

Home exercise

Other

Patients with upper limb amputation using myoelectric prosthesis will done home exercise program

Primary outcomes

Kinematic data

Time frame: 1 day

range of motion (ROM): unit is degree

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Jul 24, 2019
Registry last updated: Dec 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed