- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03094208
The Effects of Dual Task Balance Training In Individuals With Above Knee Amputation
March 22, 2017 updated by: Senem Demirdel, Hacettepe University
Investigation of the Effects of Dual Task Balance Training In Indıvıduals With Above Knee Amputation
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Senem Demirdel, MSc
- Phone Number: 138 +903123051576
- Email: sdemirdel@hacettepe.edu.tr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: study group
muscle strengthening, weight transfer, dual task balance exercises, dual task gait exercises.
|
balance exercises with cognitive and motor dual tasks
Other Names:
|
Active Comparator: control group
muscle strengthening, weight transfer, balance exercises, gait exercises.
|
balance exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
gait speed
Time Frame: 1 minute
|
10 meter walk test
|
1 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
gait analysis
Time Frame: 1 minute
|
gait analysis with footprint method
|
1 minute
|
cognition
Time Frame: 5 minutes
|
Montreal Cognitive Assessment
|
5 minutes
|
depression
Time Frame: 3 minutes
|
Beck Depression invertory
|
3 minutes
|
balance
Time Frame: 2 minutes
|
one leg stance test
|
2 minutes
|
balance
Time Frame: 1 minute
|
four square step test
|
1 minute
|
functional mobility
Time Frame: 1 minute
|
timed up and go test
|
1 minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 16, 2017
Primary Completion (Anticipated)
June 15, 2018
Study Completion (Anticipated)
August 15, 2018
Study Registration Dates
First Submitted
March 15, 2017
First Submitted That Met QC Criteria
March 22, 2017
First Posted (Actual)
March 29, 2017
Study Record Updates
Last Update Posted (Actual)
March 29, 2017
Last Update Submitted That Met QC Criteria
March 22, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- GO16/641-16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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