AmputationNCT03094208
The Effects of Dual Task Balance Training In Individuals With Above Knee Amputation
A study testing dual task balance training and traditional balance training in people with Amputation, run by Hacettepe University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amputation
- What is being tested?
- dual task balance training and traditional balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 16 Jun 2017to 15 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peoples with transfemoral amputations
- people who use their mechanical prosthetics at least 1 year
- People who can walk withoud aids
Who cannot join
- People who have the other health conditions
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Amputation
- Being tested
- dual task balance training, traditional balance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual task balance trainingOther
Also called Study group will also receive dual task balance training
balance exercises with cognitive and motor dual tasks
traditional balance trainingOther
balance exercises
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | muscle strengthening, weight transfer, dual task balance exercises, dual task gait exercises. Receives: Other: dual task balance training |
| control group | Active comparator | muscle strengthening, weight transfer, balance exercises, gait exercises. Receives: Other: traditional balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
gait speed
10 meter walk test
Measured: 1 minute
Secondary outcomes (6)
gait analysis
gait analysis with footprint method
Measured: 1 minute
cognition
Montreal Cognitive Assessment
Measured: 5 minutes
depression
Beck Depression invertory
Measured: 3 minutes
balance
one leg stance test
Measured: 2 minutes
balance
four square step test
Measured: 1 minute
functional mobility
timed up and go test
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start16 Jun 2017 (estimated)
- Primary completion15 Jun 2018 (estimated)
- Study completion15 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Senem Demirdel, Hacettepe University
- Investigators
- Fatih Erbahçeci, Prof, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094208
- Sponsor's protocol ID
- GO16/641-16
- Status last verified
- Mar 2017
- First submitted
- 15 Mar 2017
- Last updated
- 29 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 26209423Kim 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.
PubMed 24567664Monjezi 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.
PubMed 27006419Demirdel 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.
PubMed 32653580
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Dual Task Balance Training In Indıvıduals With Above Knee Amputation
- ClinicalTrials.gov ID
- NCT03094208
- Acronym / sponsor ID
- GO16/641-16
- Conditions
- Amputation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 16 Jun 2017 (estimated)
- Primary completion
- 15 Jun 2018 (estimated)
- Study completion
- 15 Aug 2018 (estimated)
- First posted
- 29 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: dual task balance trainingmuscle strengthening, weight transfer, dual task balance exercises, dual task gait exercises. |
| control group | Active comparator | Other: traditional balance trainingmuscle strengthening, weight transfer, balance exercises, gait exercises. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Peoples with transfemoral amputations
- people who use their mechanical prosthetics at least 1 year
- People who can walk withoud aids
Key exclusion criteria (1 listed)
- People who have the other health conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dual task balance trainingAlso: Study group will also receive dual task balance trainingbalance exercises with cognitive and motor dual tasks | Other | study group |
| traditional balance trainingbalance exercises | Other | control group |
Primary outcome
gait speed
Time frame: 1 minute
10 meter walk test
6 secondary outcomes
gait analysis
Time frame: 1 minute
cognition
Time frame: 5 minutes
depression
Time frame: 3 minutes
balance
Time frame: 2 minutes
balance
Time frame: 1 minute
functional mobility
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Background: PubMed 26209423Morgan 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.
- Background: PubMed 24567664Kim 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.
- Background: PubMed 27006419Monjezi 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.
- Derived from this study: PubMed 32653580Demirdel 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatih Erbahçeci, Prof principal investigator
Hacettepe University
Questions about this trial
What is this clinical trial studying?
A study testing dual task balance training and traditional balance training in people with Amputation, run by Hacettepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Senem Demirdel, MSc (+903123051576 ext. 138, sdemirdel@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gait speed (time frame: 1 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03094208, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.