StrokeHAL-RCT-IINCT02545088
New Technology for Individualised, Intensive Training of Gait After Stroke- Study II
A study testing Hybrid Assistive Limb (HAL) in people with Stroke and Ambulation Difficulty, run by Danderyd Hospital at 1 site 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 70 years
- Conditions the study is for
- Stroke, Ambulation Difficulty, Hemiparesis
- What is being tested?
- Hybrid Assistive Limb (HAL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2015to Oct 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Rehabilitation Medicine, Danderyd Hospital
Danderyd, Stockholm County, 18288
About this study
Official title: New Technology for Individualised, Intensive Training of Gait After Stroke- Phase II Trials, 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.
Read the 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
- Conditions
- Stroke, Ambulation Difficulty, Hemiparesis
- Being tested
- Hybrid Assistive Limb (HAL), 1st control group, 2nd control group
- 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, 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 groupOther
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 groupOther
The 2nd control group will not receive an intervention.
| Study group | Role | What they receive |
|---|---|---|
| Study group Hybrid Assistive Limb (HAL) | Experimental | Not described Receives: Device: Hybrid Assistive Limb (HAL) |
| 1st control group | Active comparator | Not described Receives: Other: 1st control group |
| 2nd control group | Active comparator | Not described Receives: Other: 2nd control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6 min walk test
walking ability and endurance
Measured: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Secondary outcomes (28)
Fugl Meyer Scale for lower extremities
Sensory and motor function in lower extremities
Measured: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Modified Ashworth Scale
Spasticity
Measured: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Spasticity measured with Neuroflexor foot module
Spasticity
Measured: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Berg Balance Scale
Balance
Measured: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
10 meters walk test
Walking
Measured: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
2 minutes walk test
Walking
Measured: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Functional Ambulation Categories
Walking
Measured: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Borg Rating of Perceived Exertion Scale (RPE)
Interview
Measured: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Montreal Cognitive Assessment
Measured: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Hospital anxiety and Depression Scale
Interview
Measured: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Barthel Index
Independence in mobility and personal care
Measured: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Stroke Impact Scale
Functioning and disability, Interview
Measured: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Physical activity in everyday life using SenseWear
Registers physical activity in everyday life
Measured: Assessment at baseline, after 3 weeks of intervention, after 6 weeks of intervention, 6 and 12 month post intervention
Objectively quantify the impairment caused by a stroke, using the National Institutes of Health Stroke Scale (NIHSS)
Stroke severity
Measured: Assessment at baseline
Modified Ranking Scale
Interview
Measured: Assessment at baseline
Body Mass Index
Measured: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Weight
Measured: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Height
Measured: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Blood pressure
Registered in everyday life
Measured: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
HbA1c
Blood test
Measured: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Plasma lipid profile
Blood test
Measured: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Perception of the intervention
Interview. Study group using Hybrid Assistive Limb (HAL) only.
Measured: after 6 weeks of intervention
Smoking
Interview
Measured: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Alcohol
Interview
Measured: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Drug use
From medical records
Measured: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Health care consumption
From County Council
Measured: 12 month post intervention
Stroke type and localization
From medical records
Measured: At baseline
Dysexecutive Questionnaire
Filled in by significant other
Measured: At baseline
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 startOct 2015
- Primary completionSep 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 48 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
- NCT02545088
- Sponsor's protocol ID
- HAL-RCT-Phase II-Study II
- Acronym
- HAL-RCT-II
- Status last verified
- Dec 2020
- First submitted
- 24 Aug 2015
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- 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 25859191Bergqvist M, Moller MC, Bjorklund M, Borg J, Palmcrantz S. The impact of visuospatial and executive function on activity performance and outcome after robotic or conventional gait training, long-term after stroke-as part of a randomized controlled trial. PLoS One. 2023 Mar 9;18(3):e0281212. doi: 10.1371/journal.pone.0281212. eCollection 2023.
PubMed 36893079Palmcrantz S, Wall A, Vreede KS, Lindberg P, Danielsson A, Sunnerhagen KS, Hager CK, Borg J. Impact of Intensive Gait Training With and Without Electromechanical Assistance in the Chronic Phase After Stroke-A Multi-Arm Randomized Controlled Trial With a 6 and 12 Months Follow Up. Front Neurosci. 2021 Apr 22;15:660726. doi: 10.3389/fnins.2021.660726. eCollection 2021.
PubMed 33967683
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. 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 II
- ClinicalTrials.gov ID
- NCT02545088
- Acronym / sponsor ID
- HAL-RCT-II / HAL-RCT-Phase II-Study II
- Conditions
- Stroke, Ambulation Difficulty, Hemiparesis
- Keywords
- Rehabilitation, Robotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Collaborators
- University of Tsukuba, Sahlgrenska University Hospital, Umeå University
- Study start
- Oct 2015 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Oct 2019 (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 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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study group Hybrid Assistive Limb (HAL) | Experimental | Device: Hybrid Assistive Limb (HAL) |
| 1st control group | Active comparator | Other: 1st control group |
| 2nd control group | Active comparator | Other: 2nd control group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
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, 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. | Device | Study group Hybrid Assistive Limb (HAL) |
| 1st control groupConventional gait training performed 1 session/day, 3 days/week for 6 weeks that will not exceed 1h 30 min effective training time. | Other | 1st control group |
| 2nd control groupThe 2nd control group will not receive an intervention. | Other | 2nd control group |
Primary outcome
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
28 secondary outcomes
Fugl Meyer Scale for lower extremities
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Modified Ashworth Scale
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Spasticity measured with Neuroflexor foot module
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Berg Balance Scale
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
10 meters walk test
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
2 minutes walk test
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Functional Ambulation Categories
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Borg Rating of Perceived Exertion Scale (RPE)
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Montreal Cognitive Assessment
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Hospital anxiety and Depression Scale
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Barthel Index
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Stroke Impact Scale
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
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
Objectively quantify the impairment caused by a stroke, using the National Institutes of Health Stroke Scale (NIHSS)
Time frame: Assessment at baseline
Modified Ranking Scale
Time frame: Assessment at baseline
Body Mass Index
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Weight
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Height
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Blood pressure
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
HbA1c
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Plasma lipid profile
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Perception of the intervention
Time frame: after 6 weeks of intervention
Smoking
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Alcohol
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Drug use
Time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Health care consumption
Time frame: 12 month post intervention
Stroke type and localization
Time frame: At baseline
Dysexecutive Questionnaire
Time frame: At baseline
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 19 Dec 2020.
- 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.
- Derived from this study: PubMed 36893079Bergqvist M, Moller MC, Bjorklund M, Borg J, Palmcrantz S. The impact of visuospatial and executive function on activity performance and outcome after robotic or conventional gait training, long-term after stroke-as part of a randomized controlled trial. PLoS One. 2023 Mar 9;18(3):e0281212. doi: 10.1371/journal.pone.0281212. eCollection 2023.
- Derived from this study: PubMed 33967683Palmcrantz S, Wall A, Vreede KS, Lindberg P, Danielsson A, Sunnerhagen KS, Hager CK, Borg J. Impact of Intensive Gait Training With and Without Electromechanical Assistance in the Chronic Phase After Stroke-A Multi-Arm Randomized Controlled Trial With a 6 and 12 Months Follow Up. Front Neurosci. 2021 Apr 22;15:660726. doi: 10.3389/fnins.2021.660726. eCollection 2021.
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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.
1 site 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) in people with Stroke and Ambulation Difficulty, run by Danderyd Hospital at 1 site in Sweden.
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 3 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 19 Dec 2020. 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 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 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 6 min walk test (time frame: Assessment at baseline, after 6 weeks of intervention, 6 and 12 month 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 NCT02545088, which also lists 4 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 19 Dec 2020.