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Completed

NCT Number: NCT02545088

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Rehabilitation Medicine, Danderyd Hospital

Danderyd, Stockholm County, 18288, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Hybrid Assistive Limb (HAL)

Device

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.

1st control group

Other

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

2nd control group

Other

The 2nd control group will not receive an intervention.

Primary outcomes

  1. Change in 6 min walk test

    Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

    walking ability and endurance

Secondary outcomes

  1. Fugl Meyer Scale for lower extremities

    Time frame: 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

    Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

    Spasticity

  3. Spasticity measured with Neuroflexor foot module

    Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

    Spasticity

  4. Berg Balance Scale

    Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

    Balance

  5. 10 meters walk test

    Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

    Walking

  6. 2 minutes walk test

    Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

    Walking

  7. Functional Ambulation Categories

    Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

    Walking

  8. Borg Rating of Perceived Exertion Scale (RPE)

    Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

    Interview

  9. Montreal Cognitive Assessment

    Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

  10. Hospital anxiety and Depression Scale

    Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

    Interview

  11. Barthel Index

    Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

    Independence in mobility and personal care

  12. Stroke Impact Scale

    Time frame: 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

    Time frame: 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)

    Time frame: Assessment at baseline

    Stroke severity

  15. Modified Ranking Scale

    Time frame: Assessment at baseline

    Interview

  16. Body Mass Index

    Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

  17. Weight

    Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

  18. Height

    Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

  19. Blood pressure

    Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

    Registered in everyday life

  20. HbA1c

    Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

    Blood test

  21. Plasma lipid profile

    Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

    Blood test

  22. Perception of the intervention

    Time frame: after 6 weeks of intervention

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

  23. Smoking

    Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

    Interview

  24. Alcohol

    Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

    Interview

  25. Drug use

    Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

    From medical records

  26. Health care consumption

    Time frame: 12 month post intervention

    From County Council

  27. Stroke type and localization

    Time frame: At baseline

    From medical records

  28. Dysexecutive Questionnaire

    Time frame: At baseline

    Filled in by significant other

Sponsors and collaborators

Lead sponsor

Danderyd Hospital

Other

Collaborators

  • Sahlgrenska University Hospital
  • Umeå University
  • University of Tsukuba

Registry information

Official study title

New Technology for Individualised, Intensive Training of Gait After Stroke- Phase II Trials, Study II

Acronym: HAL-RCT-II

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 9, 2015
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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