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StrokeGASPARNCT02808078

Gait Adaptation for Stroke Patients With Augmented Reality

A study testing Gait training with augmented reality and Standard training in people with Stroke and Traumatic Brain Injury, run by Philippe Terrier at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The GASPAR trial is a pragmatic, parallel-arms, single-center, non-blinded, superiority randomized control trial in neurorehabilitation. The main objective is to test whether a 4 weeks gait rehabilitation program that uses augmented reality is superior to a conventional treadmill training program of equivalent… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Traumatic Brain Injury, Spinal Cord Injury
What is being tested?
Gait training with augmented reality and Standard training
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteSwitzerland
Study dates
Jun 2016to Dec 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Participants fulfilling all of the following inclusion criteria are eligible for the study:

  • Informed Consent as documented by signature
  • Stroke patients, patients with traumatic brain injury, or patients with spinal cord injury in the acute to sub-acute phase (maximum 40 days after the incident)
  • Need for gait rehabilitation in reason of at least one of the following conditions: Paresis of the lower extremities. Severe balance disorders. No walking at entry due to the neurological injury
  • Ability to walk 2 minutes without or with minimal aid, namely: With the help of one person, or: With walking aid (cane, walker)

The presence of any one of the following exclusion criteria will lead to exclusion of the participant:

  • Age < 18 years
  • Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) that may threaten the health in case of sustained exercise.
  • Concomitant gait disorders induced by acute to sub-acute musculoskeletal injuries, e.g. fracture of the lower extremities.
  • Severe pre-existent gait disorders that deeply affect walking abilities and gait pattern, either due to musculoskeletal (e.g. severe osteoarthritis) or neurological (e.g. Parkinson's disease) etiologies.
  • Severe non-corrected visual impairment
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.

Trial locations and contacts

1 site in 1 country.

Philippe Terrier, PhD contact

+41 27 603 2077

Philippe.Terrier@crr-suva.ch

Cathia Rossano, MSc contact

+41 27 603 2073

Cathia.Rossano@crr-suva.ch

Switzerland1 site, 1 recruiting

  • Clinique Romande de Réadaptation

    Sion, Valais, 1951

    Philippe Terrier, PhD, Philippe.Terrier@crr-suva.ch

    Rossano Cathia, MSc, Cathia.Rossano@crr-suva.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: Visually-guided Gait Training in Paretic Patients During First Rehabilitation: a Randomized Controlled Trial

The GASPAR trial is a pragmatic, parallel-arms, single-center, non-blinded, superiority randomized control trial in neurorehabilitation. The main objective is to test whether a 4 weeks gait rehabilitation program that uses augmented reality is superior to a conventional treadmill training program of equivalent intensity. Baseline assessments precede allocation, which consists in blocking randomization (2:1 ratio) with stratification according to the disease etiology. Post-intervention assessments serve to compare the short-term efficacy of the intervention between the two groups. Three months after discharge, follow-up assessments take place to detect potential long-term effects.

Read the detailed description

After a lesion to the central nervous system, many patients suffer from a diminished walking capability. During the first rehabilitation phase, specific cares help the recovery of motor function to offer the best chances of returning to normal walk. For example, the repeated practice of walking exercises facilitates the gain of muscular strength and stimulates motor relearning. However, in patients, who have finished the first rehabilitation phase, it is often observed strong limping, unsteady gait, and a bad management of obstacle clearance. Thus, these individuals fall frequently, with risk of severe injury. The aim of the study is to assess the efficacy of gait training on a treadmill equipped with an augmented reality system. Shapes are displayed onto the treadmill belt with a projector (beamer): the patient adapts his/her gait to the drawing that unfolds in front of him/her. It is possible to train gait symmetry for coordination enhancement or to exercise obstacle clearance and gait agility. Another advantage of this type of treadmill is the capability to continuously analyze gait with integrated sensors and, hence, to give real-time feedback to the patient. Whereas the method seems promising, thorough studies that would confirm its efficacy are lacking. Therefore, the investigators seek to conduct a randomized controlled trial to compare visually-guided gait training with a more classical training method. During four weeks, participants will train, according to their abilities, three to five times a week during 30 minutes on the augmented-reality treadmill. A group of control patients will train at comparable intensity but without the visual guidance of gait. Using the data collected during the training sessions, the investigators will study whether the evolution of locomotor function differs between both groups. Furthermore, several questionnaires will be filled in by the participants to document the self-evaluation of their progress. In the long term, the investigators expect to first improve the efficacy of gait rehabilitation and second to better understand the recovery process of locomotor function during the first months after a stroke.

Being tested
Gait training with augmented reality, Standard training
Keywords
Instrumented treadmill, Augmented reality, Neurorehabilitation, Gait disorders
Medical subject headings
Stroke, Brain Injuries, Traumatic, Spinal Cord Injuries, Mobility Limitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gait training with augmented realityDevice

    20 sessions (30 min. duration) over 4 weeks of gait training with augmented reality.

  • Standard trainingDevice

    20 sessions (30 min. duration) over 4 weeks of gait training without augmented reality.

Study groups in NCT02808078
Study groupRoleWhat they receive
Augmented reality trainingExperimentalGait training with augmented reality
Receives: Device: Gait training with augmented reality
Standard trainingActive comparatorGait training without augmented reality
Receives: Device: Standard training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in walking speed

    Walking speed, measured with the 2-minute walk test

    Measured: Pre-intervention (week 0), Post-intervention (week 5)

Secondary outcomes (12)

  1. Change in postural control

    Capabilities to ensure an optimal postural control. Measured with the Berg Balance test

    Measured: Pre-intervention (week 0), Post-intervention (week 5)

  2. Fear of falling during the hospitalization

    Subjective assessment of the fear of falling. Measured with the adapted Falls Efficacy Scale (FES)

    Measured: week 5

  3. Fear of falling at home

    Subjective assessment of the fear of falling. Measured with the adapted Falls Efficacy Scale (FES)

    Measured: after discharge at 3-4 month

  4. Quality of life at home

    Short-Form 36 questionnaire (SF-36)

    Measured: after discharge at 3-4 month

  5. Perception of the intervention

    purpose-designed questionnaire that will ask to the participant about their perception of the intervention. The questionnaire will evaluate the satisfaction with intensity, duration and difficulty of the intervention. Other questions will ask about the perceived training effects on walking speed and confidence.

    Measured: During the intervention, week 2 and 4

  6. Changes in stride and step lengths

    Measured with the embedded sensors of the treadmills

    Measured: In every gait training sessions, from week 1 to week 4

  7. Changes in stride and step durations

    Measured with the embedded sensors of the treadmills

    Measured: In every gait training sessions, from week 1 to week 4

  8. Change in step width

    Measured with the embedded sensors of the treadmills

    Measured: In every gait training sessions, from week 1 to week 4

  9. Change in left/right asymmetry of step lengths

    Measured with the embedded sensors of the treadmills

    Measured: In every gait training sessions, from week 1 to week 4

  10. Change in left/right asymmetry of step durations

    Measured with the embedded sensors of the treadmills

    Measured: In every gait training sessions, from week 1 to week 4

  11. Changes in stance and swing phases

    Measured with the embedded sensors of the treadmills

    Measured: In every gait training sessions, from week 1 to week 4

  12. Change in gait variability

    Stride-to-stride variability of gait parameters (outcomes 7-12)

    Measured: In every gait training sessions, from week 1 to week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionJul 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

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
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02808078
Sponsor's protocol ID
CliniqueRR-04
Acronym
GASPAR
Status last verified
Dec 2017
First submitted
14 Jun 2016
Last updated
6 Dec 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: At the end of the study, final anonymized database will be made available through a specialized online repository

Publications

  • Rossano C, Terrier P. Visually-guided gait training in paretic patients during the first rehabilitation phase: study protocol for a randomized controlled trial. Trials. 2016 Oct 27;17(1):523. doi: 10.1186/s13063-016-1630-8.

    PubMed 27788679

Questions about this trial

What is this clinical trial studying?

A study testing Gait training with augmented reality and Standard training in people with Stroke and Traumatic Brain Injury, run by Philippe Terrier at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 6 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 Switzerland. 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 Philippe Terrier, PhD (+41 27 603 2077, Philippe.Terrier@crr-suva.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in walking speed (time frame: Pre-intervention (week 0), Post-intervention (week 5)). 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 NCT02808078, 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 6 Dec 2017.

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