Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

The Effects of Dual Task Balance Training In Individuals With Above Knee Amputation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03094208
Recruitment Status : Unknown
Verified March 2017 by Senem Demirdel, Hacettepe University.
Recruitment status was:  Not yet recruiting
First Posted : March 29, 2017
Last Update Posted : March 29, 2017
Information provided by (Responsible Party):
Senem Demirdel, Hacettepe University

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.

Condition or disease Intervention/treatment Phase
Amputation Other: dual task balance training Other: traditional balance training Not Applicable

Detailed Description:
The people who have transfemoral amputation may have poor balance and gait. Many people with lower limb loss report the need to concentration on gait. People with lower limb loss may need to use cognitive resources to monitor and control movements of the prosthetic limb. The need to concentrate on walking may be greater for those with transfemoral amputation. For examine the use of cognitive resources, dual task paradigm may use. Dual task rehabilitative training used in many patients like stroke, Multipl sclerosis osteoporosis. But there is no study about dual task training on amputation. The purpose of this randomized controlled study is to investigate the effects of dual-task balance training on balance and gait of patients with transfemoral amputation as compared with single-task balance training. We hypothesized that dual-task balance training would improve the balance and gait, it would be more effective than single-task balance training.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Investigation of the Effects of Dual Task Balance Training In Indıvıduals With Above Knee Amputation
Estimated Study Start Date : June 16, 2017
Estimated Primary Completion Date : June 15, 2018
Estimated Study Completion Date : August 15, 2018

Arm Intervention/treatment
Experimental: study group
muscle strengthening, weight transfer, dual task balance exercises, dual task gait exercises.
Other: dual task balance training
balance exercises with cognitive and motor dual tasks
Other Name: Study group will also receive dual task balance training

Active Comparator: control group
muscle strengthening, weight transfer, balance exercises, gait exercises.
Other: traditional balance training
balance exercises

Primary Outcome Measures :
  1. gait speed [ Time Frame: 1 minute ]
    10 meter walk test

Secondary Outcome Measures :
  1. gait analysis [ Time Frame: 1 minute ]
    gait analysis with footprint method

  2. cognition [ Time Frame: 5 minutes ]
    Montreal Cognitive Assessment

  3. depression [ Time Frame: 3 minutes ]
    Beck Depression invertory

  4. balance [ Time Frame: 2 minutes ]
    one leg stance test

  5. balance [ Time Frame: 1 minute ]
    four square step test

  6. functional mobility [ Time Frame: 1 minute ]
    timed up and go test

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • People who have the other health conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03094208

Layout table for location contacts
Contact: Senem Demirdel, MSc +903123051576 ext 138

Sponsors and Collaborators
Hacettepe University
Layout table for investigator information
Principal Investigator: Fatih Erbahçeci, Prof Hacettepe University

Layout table for additonal information
Responsible Party: Senem Demirdel, Hacettepe University Identifier: NCT03094208    
Other Study ID Numbers: GO16/641-16
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No