StrokeHAL-RCT-IINCT02545205
New Technology for Individualised, Intensive Training of Gait After Stroke Study I
A study testing Hybrid Assistive Limb (HAL) and Conventional gait training in people with Stroke and Ambulation Difficulty, run by Danderyd Hospital at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Stroke, Ambulation Difficulty, Hemiparesis
- What is being tested?
- Hybrid Assistive Limb (HAL) and Conventional gait training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Jan 2018to 1 Sep 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 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Patients aged 18-67 will be recruited from 1) the University Department of Rehabilitation Medicine at Danderyd Hospital in Stockholm and 2) Sahlgrenska University Hospital in Gothenburg, where they are admitted to inpatient rehabilitation early after stroke. Inclusion criteria will be: less than 8 weeks since stroke onset; inability to walk independently due to lower extremity paresis (i.e. Functional Ambulation Categories (FAC) score 0-1), able to sit on a bench with or-without supervision at least 5 minutes; sufficient postural control to allow upright position in standing with aids and/or manual support; ability to understand training instructions as well as written and oral study information and to express informed consent; body size compatible with the HAL suit. Exclusion criteria include: contracture restricting gait movements at any lower limb joint; cardiovascular or other somatic condition incompatible with intensive gait training; and severe, contagious infections.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Department of Rehabilitation Medicine, Danderyd Hospital
Danderyd, Stockholm County, SE-18288
Sahlgrenska University Hospital
Gothenburg, SE-413 46
About this study
Official title: New Technology for Individualised, Intensive Training of Gait After Stroke- Phase II Trials, Study I
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 aim of this study is to explore if HAL training when combined with conventional training in the subacute stage after stroke may accelerate the recovery of independence in walking when compared to conventional training only and if recovery is related to stroke lateralization?
Read the detailed description
Patients will be randomized using a block randomization by a nurse, who is not otherwise involved in the study, into either 1) HAL training in addition to the conventional program or 2) evidence based conventional gait training only. The block randomization will be designed so that an even number of patients with left and right sided hemiparesis will have been included in each group at the end of the study.
Conventional training (including gait practice) will be performed according to current best practice (approximately 30-60 min per day, 5 days per week) and may include stepping, weight shifting, over ground walking as well as the use of a treadmill with/without body weight support (BWS).
HAL training will be performed 4 days a week for 4 weeks (i.e. 16 sessions) with the single-leg version of HAL, primarily by use of the voluntary HAL-mode (CVC mode), on a treadmill with BWS. The therapist(s) educated in the HAL method will optimize the HAL settings for each individual during each session, in order to obtain a symmetrical gait pattern as close to normal gait as possible.
Outcomes The primary outcome will be changes in the FAC-score during the intervention. FAC assesses activity in terms of independence in walking on a six-grade-ordinal-scale ranging from non-functional walking to independent walking outside. During the intervention assessments with the FAC will be performed weekly by the patients' physiotherapist responsible for conventional rehabilitation. This therapist will otherwise not be involved in the study.
Secondary outcomes include aspects of body functions assessed by use of the NIH Stroke Scale, Albert's test, Fugl-Meyer Assessment(FMA-LE) and the Modified Ashworth Scale for the lower extremities.
Activities and Participation will be assessed by use of Functional Ambulation Categories, 2 minutes walk test in self-preferred speed, Berg Balance Scale, Barthel Index and EQ5D.
Patients' perception of training will be assessed by a study specific questionnaire.
Adverse events (such as irritated skin, pain, falls) will be documented continuously in the study protocol according to a specific study form.
Assessments will be performed 1) before and 2) after the intervention with 3) a follow up at 6 months.
- Conditions
- Stroke, Ambulation Difficulty, Hemiparesis
- Being tested
- Hybrid Assistive Limb (HAL), Conventional gait training
- Keywords
- Rehabilitation, Robotics
- Medical subject headings
- Stroke, Mobility Limitation, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Assistive Limb (HAL)Device
Intensive gait training with Hybrid Assistive Limb (HAL) is performed, 1 session/day, 4 days/week during 4 weeks. Time for each session is individualised but does not exceed 60 minutes/session (effective walking time with HAL).
Conventional gait trainingOther
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 group | Role | What they receive |
|---|---|---|
| Hybrid Assistive Limb (HAL) | Experimental | Not described Receives: Device: Hybrid Assistive Limb (HAL) |
| Conventional gait training | Active comparator | Not described Receives: Other: Conventional gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Ambulation Categories (FAC)
Level of independence in walking, range 0-5
Measured: Assessed at baseline, weekly, after 4 weeks of intervention and at 6 months post intervention
Secondary outcomes (9)
Objectively quantify the impairment caused by a stroke, using the National Institutes of Health Stroke Scale (NIHSS)
Measured: At baseline
Fugl-Meyer for Lower extremities
Sensory and motor function in lower extremities
Measured: Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention
Albert's test
Spatial negelct
Measured: Assessed at baseline
2 Minutes Walk Test (MWT)
Walking
Measured: Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention
Berg Balance scale
Balance
Measured: Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention
Barthel Index
Independence in mobility and personal care
Measured: Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention
Perception of the intervention
Interview, Study group using Hybrid Assistive Limb (HAL) only.
Measured: after 4 weeks of intervention
Stroke Impact Scale (SIS)
Functioning and disability, Interview
Measured: Assessed at 6 months after intervention
EQ-5D
Health Outcome
Measured: Assessed at baseline, after 4 weeks of intervention and at 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 posted9 Sep 2015 (estimated)
- Study start1 Jan 2018
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Why it stopped: Stopped due to limited access to medical technology devices.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tsukuba, Sahlgrenska University Hospital, Umeå University
- Responsible party
- Principal investigator, Susanne Palmcrantz, Danderyd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545205
- Sponsor's protocol ID
- HAL-RCT-Phase II-Study I
- Acronym
- HAL-RCT-II
- Status last verified
- Apr 2018
- First submitted
- 24 Aug 2015
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nilsson A, Vreede KS, Haglund V, Kawamoto H, Sankai Y, Borg J. Gait training early after stroke with a new exoskeleton--the hybrid assistive limb: a study of safety and feasibility. J Neuroeng Rehabil. 2014 Jun 2;11:92. doi: 10.1186/1743-0003-11-92.
PubMed 24890413Wall A, Borg J, Palmcrantz S. Clinical application of the Hybrid Assistive Limb (HAL) for gait training-a systematic review. Front Syst Neurosci. 2015 Mar 25;9:48. doi: 10.3389/fnsys.2015.00048. eCollection 2015.
PubMed 25859191
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Technology for Individualised, Intensive Training of Gait After Stroke- Phase II Trials, Study I
- ClinicalTrials.gov ID
- NCT02545205
- Acronym / sponsor ID
- HAL-RCT-II / HAL-RCT-Phase II-Study I
- Conditions
- Stroke, Ambulation Difficulty, Hemiparesis
- Keywords
- Rehabilitation, Robotics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped due to limited access to medical technology devices.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Collaborators
- University of Tsukuba, Sahlgrenska University Hospital, Umeå University
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 9 Sep 2015 (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.
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 aim of this study is to explore if HAL training when combined with conventional training in the subacute stage after stroke may accelerate the recovery of independence in walking when compared to conventional training only and if recovery is related to stroke lateralization?
Detailed description
Patients will be randomized using a block randomization by a nurse, who is not otherwise involved in the study, into either 1) HAL training in addition to the conventional program or 2) evidence based conventional gait training only. The block randomization will be designed so that an even number of patients with left and right sided hemiparesis will have been included in each group at the end of the study.
Conventional training (including gait practice) will be performed according to current best practice (approximately 30-60 min per day, 5 days per week) and may include stepping, weight shifting, over ground walking as well as the use of a treadmill with/without body weight support (BWS).
HAL training will be performed 4 days a week for 4 weeks (i.e. 16 sessions) with the single-leg version of HAL, primarily by use of the voluntary HAL-mode (CVC mode), on a treadmill with BWS. The therapist(s) educated in the HAL method will optimize the HAL settings for each individual during each session, in order to obtain a symmetrical gait pattern as close to normal gait as possible.
Outcomes The primary outcome will be changes in the FAC-score during the intervention. FAC assesses activity in terms of independence in walking on a six-grade-ordinal-scale ranging from non-functional walking to independent walking outside. During the intervention assessments with the FAC will be performed weekly by the patients' physiotherapist responsible for conventional rehabilitation. This therapist will otherwise not be involved in the study.
Secondary outcomes include aspects of body functions assessed by use of the NIH Stroke Scale, Albert's test, Fugl-Meyer Assessment(FMA-LE) and the Modified Ashworth Scale for the lower extremities.
Activities and Participation will be assessed by use of Functional Ambulation Categories, 2 minutes walk test in self-preferred speed, Berg Balance Scale, Barthel Index and EQ5D.
Patients' perception of training will be assessed by a study specific questionnaire.
Adverse events (such as irritated skin, pain, falls) will be documented continuously in the study protocol according to a specific study form.
Assessments will be performed 1) before and 2) after the intervention with 3) a follow up at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid Assistive Limb (HAL) | Experimental | Device: Hybrid Assistive Limb (HAL) |
| Conventional gait training | Active comparator | Other: Conventional gait training |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Hybrid Assistive Limb (HAL)Intensive gait training with Hybrid Assistive Limb (HAL) is performed, 1 session/day, 4 days/week during 4 weeks. Time for each session is individualised but does not exceed 60 minutes/session (effective walking time with HAL). | Device | Hybrid Assistive Limb (HAL) |
| Conventional gait trainingThe 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. | Other | Conventional gait training |
Primary outcome
Change in Functional Ambulation Categories (FAC)
Time frame: Assessed at baseline, weekly, after 4 weeks of intervention and at 6 months post intervention
Level of independence in walking, range 0-5
9 secondary outcomes
Objectively quantify the impairment caused by a stroke, using the National Institutes of Health Stroke Scale (NIHSS)
Time frame: At baseline
Fugl-Meyer for Lower extremities
Time frame: Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention
Albert's test
Time frame: Assessed at baseline
2 Minutes Walk Test (MWT)
Time frame: Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention
Berg Balance scale
Time frame: Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention
Barthel Index
Time frame: Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention
Perception of the intervention
Time frame: after 4 weeks of intervention
Stroke Impact Scale (SIS)
Time frame: Assessed at 6 months after intervention
EQ-5D
Time frame: Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention
Results and safety
The study was stopped early (reason given: Stopped due to limited access to medical technology devices.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Background: PubMed 24890413Nilsson A, Vreede KS, Haglund V, Kawamoto H, Sankai Y, Borg J. Gait training early after stroke with a new exoskeleton--the hybrid assistive limb: a study of safety and feasibility. J Neuroeng Rehabil. 2014 Jun 2;11:92. doi: 10.1186/1743-0003-11-92.
- Background: PubMed 25859191Wall A, Borg J, Palmcrantz S. Clinical application of the Hybrid Assistive Limb (HAL) for gait training-a systematic review. Front Syst Neurosci. 2015 Mar 25;9:48. doi: 10.3389/fnsys.2015.00048. eCollection 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Assistive Limb (HAL) and Conventional gait training in people with Stroke and Ambulation Difficulty, run by Danderyd Hospital at 2 sites in Sweden.
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: stopped early, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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 was stopped early (reason given: Stopped due to limited access to medical technology devices.). Results are not available in the source record.
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 Functional Ambulation Categories (FAC) (time frame: Assessed at baseline, weekly, after 4 weeks of intervention and at 6 months post intervention). 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 NCT02545205, which also lists 2 linked publications.
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 13 Feb 2023.