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

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Senem Demirdel, Hacettepe University

Tracking Information
First Submitted Date  ICMJE March 15, 2017
First Posted Date  ICMJE March 29, 2017
Last Update Posted Date March 29, 2017
Estimated Study Start Date  ICMJE June 16, 2017
Estimated Primary Completion Date June 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
gait speed [ Time Frame: 1 minute ]
10 meter walk test
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
  • gait analysis [ Time Frame: 1 minute ]
    gait analysis with footprint method
  • cognition [ Time Frame: 5 minutes ]
    Montreal Cognitive Assessment
  • depression [ Time Frame: 3 minutes ]
    Beck Depression invertory
  • balance [ Time Frame: 2 minutes ]
    one leg stance test
  • balance [ Time Frame: 1 minute ]
    four square step test
  • functional mobility [ Time Frame: 1 minute ]
    timed up and go test
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Dual Task Balance Training In Individuals With Above Knee Amputation
Official Title  ICMJE Investigation of the Effects of Dual Task Balance Training In Indıvıduals With Above Knee Amputation
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Amputation
Intervention  ICMJE
  • Other: dual task balance training
    balance exercises with cognitive and motor dual tasks
    Other Name: Study group will also receive dual task balance training
  • Other: traditional balance training
    balance exercises
Study Arms  ICMJE
  • Experimental: study group
    muscle strengthening, weight transfer, dual task balance exercises, dual task gait exercises.
    Intervention: Other: dual task balance training
  • Active Comparator: control group
    muscle strengthening, weight transfer, balance exercises, gait exercises.
    Intervention: Other: traditional balance training
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 22, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 15, 2018
Estimated Primary Completion Date June 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03094208
Other Study ID Numbers  ICMJE GO16/641-16
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Senem Demirdel, Hacettepe University
Study Sponsor  ICMJE Hacettepe University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fatih Erbahçeci, Prof Hacettepe University
PRS Account Hacettepe University
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP