Clinical trial NCT04030585: Robot-assisted Exercise in Patients With Amputation Using Myoelectric Prosthesis
Official title: Efficacy of Robot-assisted Exercise Program in Patients With Upper Limb Amputation Using Myoelectric Prosthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prosthesis User
Amputation
Keywords: Amputation
robotic rehabilitation
Prosthesis
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-07-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment group: robot-assisted exercise program Control: Home exercise program
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Kinematic data
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study officials:
affiliation: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
name: TUGBA AYDIN, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: Aydin T, Kesiktas FN, Akbulut YD, Corum M, Ones K, Kizilkurt T, Bugdayci ND, Karacan I. The efficacy of robot-assisted training for patients with upper limb amputations who use myoelectric prostheses: a randomized controlled pilot study. Int J Rehabil Res. 2022 Mar 1;45(1):39-46. doi: 10.1097/MRR.0000000000000506.