Dual TaskNCT04392466
Comparison of Dual Task Gait Characteristics in Individuals With Amputation and Healty Individuals
An observational study of Dual Task and Amputation, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
In amputee, dual task has been found to cause a decrease in walking speed. However, there is no study of how gait characteristics are affected when the speed does not change. The aim of this study is to compare the time-distance characteristics of walking with single task, cognitive dual task, motor dual task in… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dual Task, Amputation, Gait
- What is being tested?
- walking on the treadmill
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2020to 15 Jun 2022
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Transtibial amputees, Transfemoral amputees, Healty individuals
Who may be able to join
- Using a transtibial or transfemoral prosthesis for at least 1 year,
- Between the ages of 18-65,
Who cannot join
- To be diagnosed as a neurological, orthopedic, cognitive disorder,
- Having a condition other than amputation that may affect gait.
- Having different permanent disabilities other than amputation,
- Using walking aid,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepeu
Ankara, Altındağ, 06100
senem demirdel, PhD, fzt_sb@hotmail.com
About this study
Official title: Comparison of Cognitive and Motor Dual Task Gait Characteristics in Individuals With Transtibial, Transfemoral Amputation and Healty Individuals
In amputee, dual task has been found to cause a decrease in walking speed. However, there is no study of how gait characteristics are affected when the speed does not change. The aim of this study is to compare the time-distance characteristics of walking with single task, cognitive dual task, motor dual task in transtibial, transfemoral amputee and healthy people.
Read the detailed description
Walking is a complex task in which sensory and cognitive systems must be involved. The lower extremity amputee may need to use cognitive resources to focus on walking, monitor and control the prosthetic movements. The need to use cognitive resources may be higher in those with more proximal level amputation, such as above-knee level. The role of cognition and concentration is revealed by a cognitive task performed with posture and gait control using the dual task method. The dual task paradigm provides information about the automation of the default processes that underpin good performance disclosure. This approach involves performing two tasks at the same time. Dual task is divided into primary task and secondary task. The performance of the primary task while performing a single task is recorded. If there is a drop in performance when the secondary task is added, this indicates that the primary task needs high attention.
In proximal amputations, with the lost of movement system structures, functional impairment increases. Amputation from the proximal level affects daily life activities and walking ability more. Above-knee amputees reported more functional difficulties in ambulatory ambulation than transtibial amputee.
The aim of this study is to compare the time-distance characteristics of walking with single task, cognitive dual task, motor dual task in transtibial, transfemoral amputee and healthy people.
- Conditions
- Dual Task, Amputation, Gait
- Being tested
- walking on the treadmill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walking on the treadmillOther
Participants will walk on the treadmill under single task, cognitive dual task and motor dual task conditions.
| Study group | Role | What they receive |
|---|---|---|
| Transtibial amputees | People who use transtibial prosthesis. Receives: Other: walking on the treadmill | |
| Transfemoral amputees | People who use transfemoral prosthesis. Receives: Other: walking on the treadmill | |
| Healty individuals | Healty individuals Receives: Other: walking on the treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking speed
Distance per second
Measured: Two minutes
Coefficient of variation
Stride length variability coefficient
Measured: Two minutes
Secondary outcomes (3)
Step length
Length of right and left steps in cm
Measured: Two minutes
Time on each foot
The period on right foot and left foot
Measured: Two minutes
Average step cycle
Yhe period of step cycle
Measured: Two minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start15 Feb 2020
- Primary completion12 Jun 2021 (estimated)
- Study completion15 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dual TaskStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 57 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
- NCT04392466
- Sponsor's protocol ID
- GO 20/23
- Status last verified
- May 2020
- First submitted
- 13 May 2020
- Last updated
- 21 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Demirdel S, Erbahceci F, Yazicioglu G. The effects of cognitive versus motor concurrent task on gait in individuals with transtibial amputation, transfemoral amputation and in a healthy control group. Gait Posture. 2022 Jan;91:223-228. doi: 10.1016/j.gaitpost.2021.10.036. Epub 2021 Oct 27.
PubMed 34741932
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cognitive and Motor Dual Task Gait Characteristics in Individuals With Transtibial, Transfemoral Amputation and Healty Individuals
- ClinicalTrials.gov ID
- NCT04392466
- Acronym / sponsor ID
- GO 20/23
- Conditions
- Dual Task, Amputation, Gait
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 12 Jun 2021 (estimated)
- Study completion
- 15 Jun 2022 (estimated)
- First posted
- 18 May 2020 (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.
In amputee, dual task has been found to cause a decrease in walking speed. However, there is no study of how gait characteristics are affected when the speed does not change. The aim of this study is to compare the time-distance characteristics of walking with single task, cognitive dual task, motor dual task in transtibial, transfemoral amputee and healthy people.
Detailed description
Walking is a complex task in which sensory and cognitive systems must be involved. The lower extremity amputee may need to use cognitive resources to focus on walking, monitor and control the prosthetic movements. The need to use cognitive resources may be higher in those with more proximal level amputation, such as above-knee level. The role of cognition and concentration is revealed by a cognitive task performed with posture and gait control using the dual task method. The dual task paradigm provides information about the automation of the default processes that underpin good performance disclosure. This approach involves performing two tasks at the same time. Dual task is divided into primary task and secondary task. The performance of the primary task while performing a single task is recorded. If there is a drop in performance when the secondary task is added, this indicates that the primary task needs high attention.
In proximal amputations, with the lost of movement system structures, functional impairment increases. Amputation from the proximal level affects daily life activities and walking ability more. Above-knee amputees reported more functional difficulties in ambulatory ambulation than transtibial amputee.
The aim of this study is to compare the time-distance characteristics of walking with single task, cognitive dual task, motor dual task in transtibial, transfemoral amputee and healthy people.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transtibial amputees | – | Other: walking on the treadmillPeople who use transtibial prosthesis. |
| Transfemoral amputees | – | Other: walking on the treadmillPeople who use transfemoral prosthesis. |
| Healty individuals | – | Other: walking on the treadmillHealty individuals |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Transtibial amputees, Transfemoral amputees, Healty individuals
Key inclusion criteria (2 listed)
- Using a transtibial or transfemoral prosthesis for at least 1 year,
- Between the ages of 18-65,
Key exclusion criteria (4 listed)
- To be diagnosed as a neurological, orthopedic, cognitive disorder,
- Having a condition other than amputation that may affect gait.
- Having different permanent disabilities other than amputation,
- Using walking aid,
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 |
|---|---|---|
| walking on the treadmillParticipants will walk on the treadmill under single task, cognitive dual task and motor dual task conditions. | Other | Healty individuals, Transfemoral amputees, Transtibial amputees |
Primary outcome
Walking speed
Time frame: Two minutes
Distance per second
Coefficient of variation
Time frame: Two minutes
Stride length variability coefficient
3 secondary outcomes
Step length
Time frame: Two minutes
Time on each foot
Time frame: Two minutes
Average step cycle
Time frame: Two minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Derived from this study: PubMed 34741932Demirdel S, Erbahceci F, Yazicioglu G. The effects of cognitive versus motor concurrent task on gait in individuals with transtibial amputation, transfemoral amputation and in a healthy control group. Gait Posture. 2022 Jan;91:223-228. doi: 10.1016/j.gaitpost.2021.10.036. Epub 2021 Oct 27.
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dual Task and Amputation, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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, PhD (+905432168216, fzt_sb@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking speed (time frame: Two minutes). The study lists 2 primary outcomes in all. 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 NCT04392466, which also lists 1 linked publication.
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 21 May 2020.