NCT06541379

Brief Summary

The purpose of this study is to evaluate the motor imagery ability in transradial amputees using myoelectric prosthesis, compare it with the control group and investigate its effect on functionality and proprioception.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
1mo left

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress93%
Jun 2025Jun 2026

First Submitted

Initial submission to the registry

August 1, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

August 1, 2024

Last Update Submit

November 24, 2025

Conditions

Keywords

ImageryAmputeeProstheticFunctionalMyoelectric

Outcome Measures

Primary Outcomes (1)

  • Movement Imagination Questionnaire-3

    In order to determine the imagery ability of all individuals included in the amputee and control groups, the "Movement Imagery Questionnaire-3" developed and validated and validated in Turkish will be used (internal consistency coefficient: 0.87). With the 12 items in this questionnaire, internal visual imagery, external visual imagery and kinesthetic imagery abilities will be assessed through four actions each. The actions will be actively performed by the individuals at the beginning. Then, they were asked to perform these actions as mental tasks. These mental tasks were scored using a seven-point Likert scale (1: very difficult to see, feel; 7: very easy to see, feel). In the calculation of the score, the average score of the four relevant actions will be taken for each of the three sub-dimensions.

    immediately after screening

Secondary Outcomes (7)

  • Orientate Mobile Application

    immediately after screening

  • Box and Block Test

    immediately after screening

  • Jebsen Taylor Hand Function Test (JTEFT)

    immediately after screening

  • Modified Functional Reach Test (MFUT)

    immediately after screening

  • Disabilities of the Arm Shoulder and Hand (DASH)

    immediately after screening

  • +2 more secondary outcomes

Other Outcomes (2)

  • Beck Depression Inventory

    immediately after screening

  • Standardized Mini Mental Test (SMMT)

    immediately after screening

Study Arms (2)

Transradial Amputees Using Myoelectric Prosthesis

The Standardized Mini Mental Test (SMMT) will be used to assess the cognitive status of individuals, the Beck Depression Inventory (BDI) to assess depression symptoms, the Movement Imagery Questionnaire-3 to assess motor imagery ability, the Mental Chronometry Test (MKT) to measure motor imagery time, the mobile application called "Orientate" to assess hand mental rotation task performance, the Box and Block Test to assess gross motor dexterity and functionality, the Jebsen Taylor Hand Function Test (JTEFT) to assess fine and gross motor functions of the hand, the Disabilities of the Arm Shoulder and Hand (DASH) for upper extremity functional assessment, the Modified Functional Reach Test (MFUT) to measure the dynamic balance of the trunk and the Joint Position Sense measurement to assess proprioceptive sense.

Other: No intervention

Control Healthy Group

The Standardized Mini Mental Test (SMMT) will be used to assess the cognitive status of individuals, the Beck Depression Inventory (BDI) to assess depression symptoms, the Movement Imagery Questionnaire-3 to assess motor imagery ability, the Mental Chronometry Test (MKT) to measure motor imagery time, the mobile application called "Orientate" to assess hand mental rotation task performance, the Box and Block Test to assess gross motor dexterity and functionality, the Jebsen Taylor Hand Function Test (JTEFT) to assess fine and gross motor functions of the hand, the Disabilities of the Arm Shoulder and Hand (DASH) for upper extremity functional assessment, the Modified Functional Reach Test (MFUT) to measure the dynamic balance of the trunk and the Joint Position Sense measurement to assess proprioceptive sense.

Other: No intervention

Interventions

Control Healthy GroupTransradial Amputees Using Myoelectric Prosthesis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Being an amputee using a unilateral transradial and myoelectric prosthesis and control group

You may qualify if:

  • Being an amputee using a unilateral transradial and myoelectric prosthesis
  • Having at least 6 months of prosthesis experience
  • Having a maximum score of 15 on the Beck Depression Inventory
  • Having a minimum score of 26 on the Standardized Mini Mental Test
  • Being willing to participate in the study
  • Being between the ages of 18-65
  • Having a minimum score of 26 on the Standardized Mini Mental Test
  • Having signed the Informed Voluntary Consent Form
  • Having a maximum score of 15 on the Beck Depression Inventory
  • Being literate

You may not qualify if:

  • Having another physical problem other than amputation
  • Having a diagnosed cognitive disorder
  • Not being able to read or write
  • Having any neurological, orthopedic, psychological (such as schizophrenia, psychosis) and systemic problems
  • Having an unchangeable visual or auditory disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34158, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Saimpont A, Malouin F, Durand A, Mercier C, di Rienzo F, Saruco E, Collet C, Guillot A, Jackson PL. The effects of body position and actual execution on motor imagery of locomotor tasks in people with a lower-limb amputation. Sci Rep. 2021 Jul 2;11(1):13788. doi: 10.1038/s41598-021-93240-6.

Related Links

Study Officials

  • Ayşe Yazgan

    https://www.medipol.edu.tr/

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 1, 2024

First Posted

August 7, 2024

Study Start

June 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

December 2, 2025

Record last verified: 2025-11

Locations