NCT03094208

Brief Summary

The people with transfemoral amputation who use mechanical prosthesis will be include to this study. All participants will be assessed and then they will be randomly assigned to two groups. both groups will receive traditional balance trainnig. Study group will also receive dual task balance training. Training will take 4 weeks, 3 days a week. After the training program, both groups will be assessed again and the results will compare.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Status
unknown

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

March 15, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

June 16, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2018

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

12 months

First QC Date

March 15, 2017

Last Update Submit

March 22, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • gait speed

    10 meter walk test

    1 minute

Secondary Outcomes (6)

  • gait analysis

    1 minute

  • cognition

    5 minutes

  • depression

    3 minutes

  • balance

    2 minutes

  • balance

    1 minute

  • +1 more secondary outcomes

Study Arms (2)

study group

EXPERIMENTAL

muscle strengthening, weight transfer, dual task balance exercises, dual task gait exercises.

Other: dual task balance training

control group

ACTIVE COMPARATOR

muscle strengthening, weight transfer, balance exercises, gait exercises.

Other: traditional balance training

Interventions

balance exercises with cognitive and motor dual tasks

Also known as: Study group will also receive dual task balance training
study group

balance exercises

control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Peoples with transfemoral amputations
  • people who use their mechanical prosthetics at least 1 year
  • People who can walk withoud aids

You may not qualify if:

  • People who have the other health conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Morgan SJ, Hafner BJ, Kelly VE. The effects of a concurrent task on walking in persons with transfemoral amputation compared to persons without limb loss. Prosthet Orthot Int. 2016 Aug;40(4):490-6. doi: 10.1177/0309364615596066. Epub 2015 Jul 24.

    PMID: 26209423BACKGROUND
  • Kim GY, Han MR, Lee HG. Effect of Dual-task Rehabilitative Training on Cognitive and Motor Function of Stroke Patients. J Phys Ther Sci. 2014 Jan;26(1):1-6. doi: 10.1589/jpts.26.1. Epub 2014 Feb 6.

    PMID: 24567664BACKGROUND
  • Monjezi S, Negahban H, Tajali S, Yadollahpour N, Majdinasab N. Effects of dual-task balance training on postural performance in patients with Multiple Sclerosis: a double-blind, randomized controlled pilot trial. Clin Rehabil. 2017 Feb;31(2):234-241. doi: 10.1177/0269215516639735. Epub 2016 Jul 10.

    PMID: 27006419BACKGROUND
  • Demirdel S, Erbahceci F. Investigation of the Effects of Dual-Task Balance Training on Gait and Balance in Transfemoral Amputees: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 Oct;101(10):1675-1682. doi: 10.1016/j.apmr.2020.06.009. Epub 2020 Jul 10.

Study Officials

  • Fatih Erbahçeci, Prof

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Senem Demirdel, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hacettepe University

Study Record Dates

First Submitted

March 15, 2017

First Posted

March 29, 2017

Study Start

June 16, 2017

Primary Completion

June 15, 2018

Study Completion

August 15, 2018

Last Updated

March 29, 2017

Record last verified: 2017-03