StrokeNCT01568957
Training Dual-Task Walking After Stroke
A study testing Gait training in people with Stroke, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Community ambulation is a highly complex skill requiring the ability to adapt to increased environmental complexity and perform multiple tasks simultaneously. Deficits in dual-tasking may severely compromise the ability to participate fully in community living. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Gait training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to 15 Nov 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Within 3 years of stroke onset
- Living in the community, operationally defined as living in one's own home, or the home of a friend, relative, or caregiver
- Walking speed 0.6-1.1 m/s determined during 10-meter walk test
- Walk without the assistance of another person
- Medically stable and approved for participation by study physician
- Intact global cognition indicated by score > 23 on Montreal Cognitive Assessment
- Living in the community prior to stroke
Who cannot join
- Pre-existing neurological disorders (e.g., Parkinson's disease, Multiple Sclerosis, dementia, traumatic brain injury)
- Previous stroke with residual motor deficit
- Uncontrolled hypertension
- Inability to follow 3-step command
- Primary uncontrolled hearing impairment
- Severe uncontrolled visual impairment
Show all 11Show fewer
- Any speech-language impairment affecting ability to respond verbally to auditory stimuli
- Timed Up and Go test > 15 seconds
- Lower extremity amputation
- Any orthopedic problem affecting gait
- Concurrent participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: Training Dual-Task Walking After Stroke: Effects on Attentional and Locomotor Control
Community ambulation is a highly complex skill requiring the ability to adapt to increased environmental complexity and perform multiple tasks simultaneously. Deficits in dual-tasking may severely compromise the ability to participate fully in community living. Unfortunately, current rehabilitation practice for stroke fails to adequately address dual-task limitations; individuals with stroke continue to exhibit clinically significant dual-task costs on gait at discharge. As a result, many stroke survivors are living in the community with residual deficits that may increase disability in the real world and lead to falls with devastating consequences. To address this issue, the proposed study investigates the efficacy of dual-task gait training on attention allocation and locomotor performance in community-dwelling stroke survivors. Because walking in the real world often requires time-critical tasks and obstacle avoidance, the investigators will test the impact of dual-task gait training on cognitive-motor interference during walking at preferred speed and at maximal speed (Aim 1), and on locomotor control during obstacle negotiation (Aim 2). The investigators will also evaluate the effects of the intervention on community reintegration and participation (Aim 3).
- Conditions
- Stroke
- Being tested
- Gait training
- Keywords
- Gait, Dual-task, Obstacle avoidance, Attention allocation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait trainingBehavioural
Twelve 30-minute sessions plus 10-minute stretching and warm up, provided 3 times per weeks for 4 weeks. Up to 6 weeks are allowed to complete the 12 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Dual-task gait training | Experimental | Gait training with simultaneous performance of cognitive tasks for 75% of training session. Receives: Behavioral: Gait training |
| Single-task gait training | Active comparator | Gait training (without simultaneous cognitive task performance) Receives: Behavioral: Gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual-task cost on gait speed
The dual-task cost represents the difference between single and dual-task walking speed.
Measured: 4 weeks
Secondary outcomes (4)
Executive function
A computerized version of the Stroop task will be used to assess changes in executive function.
Measured: Measured at baseline, post intervention (4 weeks), 6 months post intervention
Spontaneous physical activity
Spontaneous physical activity will be assessed with an activity monitor (PAMSys) worn for two consecutive days at each assessment timepoint.
Measured: Measured at baseline, post intervention (4 weeks), 6 months post intervention
Kinematics of gait during obstacle crossing
Measured: Measured at baseline, post intervention (4 weeks), 6 months post intervention
Stroke Impact Scale
Measured: Measured at baseline, post intervention (4 weeks), 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startSep 2011
- Primary completion29 Mar 2017
- Study completion15 Nov 2017
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 StrokeStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arizona
- Responsible party
- Sponsor
- Investigators
- Prudence Plummer, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568957
- Sponsor's protocol ID
- 11SDG7270001
- Status last verified
- Nov 2017
- First submitted
- 25 Mar 2012
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Plummer-D'Amato P, Kyvelidou A, Sternad D, Najafi B, Villalobos RM, Zurakowski D. Training dual-task walking in community-dwelling adults within 1 year of stroke: a protocol for a single-blind randomized controlled trial. BMC Neurol. 2012 Oct 31;12:129. doi: 10.1186/1471-2377-12-129.
PubMed 23113928
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Dual-Task Walking After Stroke: Effects on Attentional and Locomotor Control
- ClinicalTrials.gov ID
- NCT01568957
- Acronym / sponsor ID
- 11SDG7270001
- Conditions
- Stroke
- Keywords
- Gait, Dual-task, Obstacle avoidance, Attention allocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- University of Arizona
- Study start
- Sep 2011
- Primary completion
- 29 Mar 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 2 Apr 2012 (estimated)
- 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.
Community ambulation is a highly complex skill requiring the ability to adapt to increased environmental complexity and perform multiple tasks simultaneously. Deficits in dual-tasking may severely compromise the ability to participate fully in community living. Unfortunately, current rehabilitation practice for stroke fails to adequately address dual-task limitations; individuals with stroke continue to exhibit clinically significant dual-task costs on gait at discharge. As a result, many stroke survivors are living in the community with residual deficits that may increase disability in the real world and lead to falls with devastating consequences. To address this issue, the proposed study investigates the efficacy of dual-task gait training on attention allocation and locomotor performance in community-dwelling stroke survivors. Because walking in the real world often requires time-critical tasks and obstacle avoidance, the investigators will test the impact of dual-task gait training on cognitive-motor interference during walking at preferred speed and at maximal speed (Aim 1), and on locomotor control during obstacle negotiation (Aim 2). The investigators will also evaluate the effects of the intervention on community reintegration and participation (Aim 3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual-task gait training | Experimental | Behavioral: Gait trainingGait training with simultaneous performance of cognitive tasks for 75% of training session. |
| Single-task gait training | Active comparator | Behavioral: Gait trainingGait training (without simultaneous cognitive task performance) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Within 3 years of stroke onset
- Living in the community, operationally defined as living in one's own home, or the home of a friend, relative, or caregiver
- Walking speed 0.6-1.1 m/s determined during 10-meter walk test
- Walk without the assistance of another person
- Medically stable and approved for participation by study physician
Key exclusion criteria (11 listed)
- Pre-existing neurological disorders (e.g., Parkinson's disease, Multiple Sclerosis, dementia, traumatic brain injury)
- Previous stroke with residual motor deficit
- Uncontrolled hypertension
- Inability to follow 3-step command
- Primary uncontrolled hearing impairment
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 |
|---|---|---|
| Gait trainingTwelve 30-minute sessions plus 10-minute stretching and warm up, provided 3 times per weeks for 4 weeks. Up to 6 weeks are allowed to complete the 12 sessions. | Behavioural | Dual-task gait training, Single-task gait training |
Primary outcome
Dual-task cost on gait speed
Time frame: 4 weeks
The dual-task cost represents the difference between single and dual-task walking speed.
4 secondary outcomes
Executive function
Time frame: Measured at baseline, post intervention (4 weeks), 6 months post intervention
Spontaneous physical activity
Time frame: Measured at baseline, post intervention (4 weeks), 6 months post intervention
Kinematics of gait during obstacle crossing
Time frame: Measured at baseline, post intervention (4 weeks), 6 months post intervention
Stroke Impact Scale
Time frame: Measured at baseline, post intervention (4 weeks), 6 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Derived from this study: PubMed 23113928Plummer-D'Amato P, Kyvelidou A, Sternad D, Najafi B, Villalobos RM, Zurakowski D. Training dual-task walking in community-dwelling adults within 1 year of stroke: a protocol for a single-blind randomized controlled trial. BMC Neurol. 2012 Oct 31;12:129. doi: 10.1186/1471-2377-12-129.
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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.
Prudence Plummer, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait training in people with Stroke, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 7 inclusion and 11 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: finished, as of the sponsor's last update on 12 Dec 2017. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual-task cost on gait speed (time frame: 4 weeks). 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 NCT01568957, 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 12 Dec 2017.