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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04030585
Enrollment
12
Registered
2019-07-24
Start date
2019-07-24
Completion date
2021-11-13
Last updated
2021-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prosthesis User, Amputation

Keywords

Amputation, robotic rehabilitation, Prosthesis

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.

Interventions

DEVICERobot

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

OTHERHome exercise

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

Sponsors

Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Single blind

Intervention model description

Treatment group: robot-assisted exercise program Control: Home exercise program

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Kinematic data1 dayrange of motion (ROM): unit is degree

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026