New Technology for Individualised, Intensive Training of Gait After Stroke- Study II
HAL-RCT-II
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Oct 2015
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2015
CompletedFirst Posted
Study publicly available on registry
September 9, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedDecember 19, 2020
December 1, 2020
3.9 years
August 24, 2015
December 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in 6 min walk test
walking ability and endurance
Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Secondary Outcomes (28)
Fugl Meyer Scale for lower extremities
Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Modified Ashworth Scale
Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Spasticity measured with Neuroflexor foot module
Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Berg Balance Scale
Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
10 meters walk test
Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
- +23 more secondary outcomes
Study Arms (3)
Study group Hybrid Assistive Limb (HAL)
EXPERIMENTAL1st control group
ACTIVE COMPARATOR2nd control group
ACTIVE COMPARATORInterventions
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.
Conventional gait training performed 1 session/day, 3 days/week for 6 weeks that will not exceed 1h 30 min effective training time.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Danderyd Hospitallead
- University of Tsukubacollaborator
- Sahlgrenska University Hospitalcollaborator
- Umeå Universitycollaborator
Study Sites (1)
Department of Rehabilitation Medicine, Danderyd Hospital
Danderyd, Stockholm County, 18288, Sweden
Related Publications (4)
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.
PMID: 24890413BACKGROUNDWall 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.
PMID: 25859191BACKGROUNDBergqvist 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.
PMID: 36893079DERIVEDPalmcrantz 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.
PMID: 33967683DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, Reg physiotherapist
Study Record Dates
First Submitted
August 24, 2015
First Posted
September 9, 2015
Study Start
October 1, 2015
Primary Completion
September 1, 2019
Study Completion
October 1, 2019
Last Updated
December 19, 2020
Record last verified: 2020-12