Robot-assisted Exercise in Patients With Amputation Using Myoelectric Prosthesis

Overview

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 Title of Study: “Efficacy of Robot-assisted Exercise Program in Patients With Upper Limb Amputation Using Myoelectric Prosthesis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: November 13, 2021

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

  • 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

Arms, Groups and Cohorts

  • Experimental: robot-assisted exercise
    • Robot-assisted exercise program will applied by patients with upper limb amputation using myoelectric prosthesis
  • Active Comparator: Home exercise
    • Home exercise program will applied by patients with upper limb amputation using myoelectric prosthesis

Clinical Trial Outcome Measures

Primary Measures

  • Kinematic data
    • Time Frame: 1 day
    • range of motion (ROM): unit is degree

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Istanbul Physical Medicine Rehabilitation Training and Research Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • TUGBA AYDIN, MD, Study Chair, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

References

Biffi E, Maghini C, Cairo B, Beretta E, Peri E, Altomonte D, Mazzoli D, Giacobbi M, Prati P, Merlo A, Strazzer S. Movement Velocity and Fluidity Improve after Armeo(R)Spring Rehabilitation in Children Affected by Acquired and Congenital Brain Diseases: An Observational Study. Biomed Res Int. 2018 Nov 18;2018:1537170. doi: 10.1155/2018/1537170. eCollection 2018.

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