StrokeNCT03577353
Dual-task Training Using Virtual Reality
A study testing Dual Task Walking (DTW) and Single-task Treadmill Walking (TMW) in people with Stroke, run by Loewenstein Hospital at 1 site in Israel.
Trial summary
The purpose of the study was to investigate the feasibility of using a virtual reality- based dual task training of upper extremity tracking while treadmill-walking, to improve walking and balance performance in post stroke survivors Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Dual Task Walking (DTW) and Single-task Treadmill Walking (TMW)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Oct 2013to 26 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With hemiplegia after a stroke for at least a year since the incident.
- Range age 40-80.
- Without medication or with stabilized medication.
- Use ankle-foot orthosis or no splint at all.
Who cannot join
- Severe cardiac problems
- A score less than 25 in the Mini-Mental test.
- Fractures or severe orthopedic limitations that do not allow for training, and which have occurred over the last six months.
- More than three falls in the past year before participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dual-task Training Using Virtual Reality: Influence on Walking and Balance in Post Stroke Survivors
The purpose of the study was to investigate the feasibility of using a virtual reality- based dual task training of upper extremity tracking while treadmill-walking, to improve walking and balance performance in post stroke survivors
- Conditions
- Stroke
- Being tested
- Dual Task Walking (DTW), Single-task Treadmill Walking (TMW)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Task Walking (DTW)Behavioural
Each training session began with 8 min of general warm-up and 2 min walk around the gym. Then, for safety reasons, the participants were attached to a harness. The participants began walking slowly on the treadmill for 3 min. In the following phases the participants walked at the same speed, while training with 3 VR games. Each session lasted 3 min, and 3 min of single walking was performed between VR sessions. After the final VR session, 2 min of single-task walking was performed in order to allow for recovery. The time walked in each trial from the starting point to the destination was kept constant at 20 min.
Single-task Treadmill Walking (TMW)Behavioural
this intervention, participants performed 8 min of general warm-up and 2 min walk around the gym, and then continued to walk for another 20 min on the treadmill at a speed that was equivalent to the intensity of 60%-70% of their heart rate reserve.
| Study group | Role | What they receive |
|---|---|---|
| experimental-DTW | Experimental | The intervention of the experimental group was based on dual-task treadmill walking while using the Virtual Reality (VR) tool. Receives: Behavioral: Dual Task Walking (DTW) |
| Control- TMW | Active comparator | The intervention of the control group was based on single-task treadmill walking. Receives: Behavioral: Single-task Treadmill Walking (TMW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in 10-meter walking test across pre, post and follow-up time points.
Measured: Pre-intervention time: one week before the intervention period (4 week).Post intervention time:immediately after the intervention. Follow-up time: 4 weeks after intervention
Change in Timed up and go across pre, post and follow-up time points.
Measured: Pre-intervention time: one week before the intervention period (4 week).Post intervention time:immediately after the intervention. Follow-up time: 4 weeks after intervention
Change in Functional Reach Test across pre, post and follow-up time points.
Measured: Pre-intervention time: one week before the intervention period (4 week).Post intervention time:immediately after the intervention. Follow-up time: 4 weeks after intervention
Change in Activities-specific Balance Confidence (ABC) Scale
Activities-specific Balance Confidence (ABC) Scale is a 16-item questionnaire/survey. Each item is rated from 0% (no confidence) to 100% (complete confidence). Elderly respondents are asked to rate their confidence that they will lose their balance or become unsteady in the course of daily activities. ABC is an 11-point scale and ratings should consist of whole numbers (0-100) for each item. Participants should indicate their level of confidence in doing an activity without losing balance or becoming unsteady by choosing one of the percentage points on the scale from 0%-100%. Total the ratings (possible range = 0 to 1600) and divide by 16 to get each subject's ABC score. Scores lower than 50 indicate a low level of functioning, scores above 50 but below 80 indicate a medium level, and those over 80 indicate a high level of functioning.
Measured: Pre-intervention time: one week before the intervention period (4 week).Post intervention time:immediately after the intervention. Follow-up time: 4 weeks after intervention
Change in The Berg Balance Scale (BBS) across pre, post and follow-up time points.
14-item scale designed to measure balance of the older adult in a clinical setting. A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function.Total Score = 56. 41-56 = low fall risk, 21-40 = medium fall risk, 0 -20 = high fall risk.
Measured: Pre-intervention time: one week before the intervention period (4 week).Post intervention time:immediately after the intervention. Follow-up time: 4 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start30 Oct 2013
- Primary completion18 Aug 2016
- Study completion26 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loewenstein Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yeshayahu Hutzler, Ph.D., Study director, Graduate School Academic College at Wingate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577353
- Sponsor's protocol ID
- 0001-13-LOE
- Status last verified
- Apr 2018
- First submitted
- 21 May 2018
- Last updated
- 5 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-task Training Using Virtual Reality: Influence on Walking and Balance in Post Stroke Survivors
- ClinicalTrials.gov ID
- NCT03577353
- Acronym / sponsor ID
- 0001-13-LOE
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Loewenstein HospitalUniversity, hospital or other
- Study start
- 30 Oct 2013 (actual)
- Primary completion
- 18 Aug 2016 (actual)
- Study completion
- 26 Nov 2017 (actual)
- First posted
- 5 Jul 2018 (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 purpose of the study was to investigate the feasibility of using a virtual reality- based dual task training of upper extremity tracking while treadmill-walking, to improve walking and balance performance in post stroke survivors
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental-DTW | Experimental | Behavioral: Dual Task Walking (DTW)The intervention of the experimental group was based on dual-task treadmill walking while using the Virtual Reality (VR) tool. |
| Control- TMW | Active comparator | Behavioral: Single-task Treadmill Walking (TMW)The intervention of the control group was based on single-task treadmill walking. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- With hemiplegia after a stroke for at least a year since the incident.
- Range age 40-80.
- Without medication or with stabilized medication.
- Use ankle-foot orthosis or no splint at all.
Key exclusion criteria (4 listed)
- Severe cardiac problems
- A score less than 25 in the Mini-Mental test.
- Fractures or severe orthopedic limitations that do not allow for training, and which have occurred over the last six months.
- More than three falls in the past year before participating in the study
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 Walking (DTW)Each training session began with 8 min of general warm-up and 2 min walk around the gym. Then, for safety reasons, the participants were attached to a harness. The participants began walking slowly on the treadmill for 3 min. In the following phases the participants walked at the same speed, while training with 3 VR games. Each session lasted 3 min, and 3 min of single walking was performed between VR sessions. After the final VR session, 2 min of single-task walking was performed in order to allow for recovery. The time walked in each trial from the starting point to the destination was kept constant at 20 min. | Behavioural | experimental-DTW |
| Single-task Treadmill Walking (TMW)this intervention, participants performed 8 min of general warm-up and 2 min walk around the gym, and then continued to walk for another 20 min on the treadmill at a speed that was equivalent to the intensity of 60%-70% of their heart rate reserve. | Behavioural | Control- TMW |
Primary outcome
change in 10-meter walking test across pre, post and follow-up time points.
Time frame: Pre-intervention time: one week before the intervention period (4 week).Post intervention time:immediately after the intervention. Follow-up time: 4 weeks after intervention
Change in Timed up and go across pre, post and follow-up time points.
Time frame: Pre-intervention time: one week before the intervention period (4 week).Post intervention time:immediately after the intervention. Follow-up time: 4 weeks after intervention
Change in Functional Reach Test across pre, post and follow-up time points.
Time frame: Pre-intervention time: one week before the intervention period (4 week).Post intervention time:immediately after the intervention. Follow-up time: 4 weeks after intervention
Change in Activities-specific Balance Confidence (ABC) Scale
Time frame: Pre-intervention time: one week before the intervention period (4 week).Post intervention time:immediately after the intervention. Follow-up time: 4 weeks after intervention
Activities-specific Balance Confidence (ABC) Scale is a 16-item questionnaire/survey. Each item is rated from 0% (no confidence) to 100% (complete confidence). Elderly respondents are asked to rate their confidence that they will lose their balance or become unsteady in the course of daily activities. ABC is an 11-point scale and ratings should consist of whole numbers (0-100) for each item. Participants should indicate their level of confidence in doing an activity without losing balance or becoming unsteady by choosing one of the percentage points on the scale from 0%-100%. Total the ratings (possible range = 0 to 1600) and divide by 16 to get each subject's ABC score. Scores lower than 50 indicate a low level of functioning, scores above 50 but below 80 indicate a medium level, and those over 80 indicate a high level of functioning.
Change in The Berg Balance Scale (BBS) across pre, post and follow-up time points.
Time frame: Pre-intervention time: one week before the intervention period (4 week).Post intervention time:immediately after the intervention. Follow-up time: 4 weeks after intervention
14-item scale designed to measure balance of the older adult in a clinical setting. A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function.Total Score = 56. 41-56 = low fall risk, 21-40 = medium fall risk, 0 -20 = high fall risk.
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 5 Jul 2018.
- 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.
Yeshayahu Hutzler, Ph.D. study director
Graduate School Academic College at Wingate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual Task Walking (DTW) and Single-task Treadmill Walking (TMW) in people with Stroke, run by Loewenstein Hospital at 1 site in Israel.
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 4 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: finished, as of the sponsor's last update on 5 Jul 2018. 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 Israel. 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?
change in 10-meter walking test across pre, post and follow-up time points. (time frame: Pre-intervention time: one week before the intervention period (4 week).Post intervention time:immediately after the intervention. Follow-up time: 4 weeks after intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2018.