Robot-assisted Exercise in Patients With Amputation Using Myoelectric Prosthesis

Amputation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04030585
• Other study ID #: MYO-2019
• Status: Completed
• Phase: N/A
• Start date: July 24, 2019
• Est. completion date: November 13, 2021

Study information

• Verified date: December 2021
• Source: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 13, 2021
• Est. primary completion date: November 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Amputation
• Prosthesis User

Intervention

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

Locations

Country	Name	City	State
Turkey	Istanbul Physical Medicine Rehabilitation Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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®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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinematic data	range of motion (ROM): unit is degree	1 day