NCT04030585

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

July 24, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2021

Completed
Last Updated

December 17, 2021

Status Verified

December 1, 2021

Enrollment Period

2.3 years

First QC Date

July 22, 2019

Last Update Submit

December 16, 2021

Conditions

Prosthesis UserAmputation

Keywords

Amputationrobotic rehabilitationProsthesis

Outcome Measures

Primary Outcomes (1)

  • Kinematic data

    range of motion (ROM): unit is degree

    1 day

Study Arms (2)

robot-assisted exercise

EXPERIMENTAL

Robot-assisted exercise program will applied by patients with upper limb amputation using myoelectric prosthesis

Device: Robot

Home exercise

ACTIVE COMPARATOR

Home exercise program will applied by patients with upper limb amputation using myoelectric prosthesis

Other: Home exercise

Interventions

RobotDEVICE

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

robot-assisted exercise
Home exerciseOTHER

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

Home exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with neurological sequelae
  • Patients who could not cooperate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, 34192, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 30581845BACKGROUND

  • 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.

    PMID: 34775437DERIVED

MeSH Terms

Interventions

Robotic Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgery, Computer-AssistedSurgical Procedures, OperativeRoboticsAutomationTechnologyTechnology, Industry, and Agriculture

Study Officials

  • TUGBA AYDIN, MD

    Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Treatment group: robot-assisted exercise program Control: Home exercise program
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2019

First Posted

July 24, 2019

Study Start

July 24, 2019

Primary Completion

November 13, 2021

Study Completion

November 13, 2021

Last Updated

December 17, 2021

Record last verified: 2021-12

Locations

TU(1)