HAL-RCT-II: New Technology for Individualised, Intensive Training of Gait After Stroke- Study II

Sponsor
Danderyd Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02545088
Collaborator
University of Tsukuba (Other), Sahlgrenska University Hospital, Sweden (Other), Umeå University (Other)
48
1
3
48
1

Study Details

Study Description

Brief Summary

The overall purpose of this project is to establish the added value of training with the Hybrid Assistive Limb (HAL) exoskeleton system as part of regular rehabilitation intervention programs after stroke.

The main specific aims are:

(i) to compare potential effects on functioning and disability of gait and mobility training long-term after stroke by comparing A) HAL-training combined with conventional rehabilitation interventions to B) conventional rehabilitation interventions without HAL and to C) no intervention.

Condition or Disease Intervention/Treatment Phase
  • Device: Hybrid Assistive Limb (HAL)
  • Other: 1st control group
  • Other: 2nd control group
N/A

Detailed Description

The effectiveness of the interventions will be assessed in terms aspects of body function, walking ability and endurance as well as level of activity in daily living and participation assessed at the end of intervention and at a 6 and 12 months follow-up.

Intensive gait training with HAL is performed 1 session/day, 3 days/week for 6 weeks and each session will not exceed 60 min of effective walking time with HAL. In addition, each session will include conventional gait training that will not exceed 30 min effective training time. To standardize the training procedure, training with HAL is performed on a treadmill and to enable body weight support. Body weight support is used to prevent falls and to unburden the weight of the suit (9 kg). The training program is performed by physiotherapists, trained in the HAL method and the study procedures. At the end of the 6 weeks, the physiotherapist that has been engaged in the patient's conventional training will perform 1-2 home visits to inform/educate the patient and those who are providing assistance to the patient in how the patient can make use of any gains in gait function during activities of daily living.

The 1st control group will receive conventional gait training performed 1 session/day, 3 days/week for 6 weeks that will not exceed 1h 30 min effective training time.

The 2nd control group will not receive an intervention. The conventional gait training is performed according to current best evidence based practice and may include over ground walking with assistance and/or assistant devices as well as the use of a treadmill and body weight support and training of gait function in activities of daily living

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
New Technology for Individualised, Intensive Training of Gait After Stroke- Phase II Trials, Study II
Actual Study Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Sep 1, 2019
Actual Study Completion Date :
Oct 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study group Hybrid Assistive Limb (HAL)

Device: Hybrid Assistive Limb (HAL)
Intensive gait training with Hybrid Assistive Limb (HAL) is performed 1 session/day, 3 days/week for 6 weeks and each session will not exceed 60 min of effective walking time with HAL. In addition, each session will include conventional gait training that will not exceed 30 min effective training time.

Active Comparator: 1st control group

Other: 1st control group
Conventional gait training performed 1 session/day, 3 days/week for 6 weeks that will not exceed 1h 30 min effective training time.

Active Comparator: 2nd control group

Other: 2nd control group
The 2nd control group will not receive an intervention.

Outcome Measures

Primary Outcome Measures

  1. Change in 6 min walk test [Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention]

    walking ability and endurance

Secondary Outcome Measures

  1. Fugl Meyer Scale for lower extremities [Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention]

    Sensory and motor function in lower extremities

  2. Modified Ashworth Scale [Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention]

    Spasticity

  3. Spasticity measured with Neuroflexor foot module [Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention]

    Spasticity

  4. Berg Balance Scale [Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention]

    Balance

  5. 10 meters walk test [Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention]

    Walking

  6. 2 minutes walk test [Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention]

    Walking

  7. Functional Ambulation Categories [Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention]

    Walking

  8. Borg Rating of Perceived Exertion Scale (RPE) [Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention]

    Interview

  9. Montreal Cognitive Assessment [Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention]

  10. Hospital anxiety and Depression Scale [Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention]

    Interview

  11. Barthel Index [Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention]

    Independence in mobility and personal care

  12. Stroke Impact Scale [Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention]

    Functioning and disability, Interview

  13. Physical activity in everyday life using SenseWear [Assessment at baseline, after 3 weeks of intervention, after 6 weeks of intervention, 6 and 12 month post intervention]

    Registers physical activity in everyday life

  14. Objectively quantify the impairment caused by a stroke, using the National Institutes of Health Stroke Scale (NIHSS) [Assessment at baseline]

    Stroke severity

  15. Modified Ranking Scale [Assessment at baseline]

    Interview

  16. Body Mass Index [Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention]

  17. Weight [Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention]

  18. Height [Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention]

  19. Blood pressure [Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention]

    Registered in everyday life

  20. HbA1c [Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention]

    Blood test

  21. Plasma lipid profile [Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention]

    Blood test

  22. Perception of the intervention [after 6 weeks of intervention]

    Interview. Study group using Hybrid Assistive Limb (HAL) only.

  23. Smoking [Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention]

    Interview

  24. Alcohol [Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention]

    Interview

  25. Drug use [Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention]

    From medical records

  26. Health care consumption [12 month post intervention]

    From County Council

  27. Stroke type and localization [At baseline]

    From medical records

  28. Dysexecutive Questionnaire [At baseline]

    Filled in by significant other

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 1-10 years since stroke onset

  • Able to walk but not independently, i.e. need of manual support or close supervision due to lower extremity paresis, FAC score 2-3 or FAC 4 combined with gait speed <0.8m/s according to 10 meter walk test, which corresponds to limitations in community ambulation (Bowden et al 2008)

  • Ability to understand training instructions as well as written and oral study information and to express informed consent or by proxy

  • Body size compatible with the HAL suit.

Exclusion Criteria:
  • Contracture restricting gait movements at any lower limb joint

  • Cardiovascular or other somatic condition incompatible with intensive gait training

  • Severe, contagious infections (e.g. Methicillin Resistant Staphylococcus Aureus (MRSA) or Extended Spectrum Beta Lactamase bacteria).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Rehabilitation Medicine, Danderyd Hospital Danderyd Stockholm Sweden 18288

Sponsors and Collaborators

  • Danderyd Hospital
  • University of Tsukuba
  • Sahlgrenska University Hospital, Sweden
  • Umeå University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Susanne Palmcrantz, PhD, Reg physiotherapist, Danderyd Hospital
ClinicalTrials.gov Identifier:
NCT02545088
Other Study ID Numbers:
  • HAL-RCT-Phase II-Study II
First Posted:
Sep 9, 2015
Last Update Posted:
Dec 19, 2020
Last Verified:
Dec 1, 2020
Keywords provided by Susanne Palmcrantz, PhD, Reg physiotherapist, Danderyd Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 19, 2020