Stroke Clinical Trial
— HAL-RCT-IIOfficial title:
New Technology for Individualised, Intensive Training of Gait After Stroke- Phase II Trials, Study I
Verified date | April 2018 |
Source | Danderyd Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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?
Status | Terminated |
Enrollment | 2 |
Est. completion date | September 1, 2018 |
Est. primary completion date | September 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 67 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Department of Rehabilitation Medicine, Danderyd Hospital | Danderyd | Stockholm |
Sweden | Sahlgrenska University Hospital | Gothenburg |
Lead Sponsor | Collaborator |
---|---|
Danderyd Hospital | Sahlgrenska University Hospital, Sweden, Umeå University, University of Tsukuba |
Sweden,
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. — View Citation
Wall 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Functional Ambulation Categories (FAC) | Level of independence in walking, range 0-5 | Assessed at baseline, weekly, after 4 weeks of intervention and at 6 months post intervention | |
Secondary | Objectively quantify the impairment caused by a stroke, using the National Institutes of Health Stroke Scale (NIHSS) | At baseline | ||
Secondary | Fugl-Meyer for Lower extremities | Sensory and motor function in lower extremities | Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention | |
Secondary | Albert's test | Spatial negelct | Assessed at baseline | |
Secondary | 2 Minutes Walk Test (MWT) | Walking | Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention | |
Secondary | Berg Balance scale | Balance | Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention | |
Secondary | Barthel Index | Independence in mobility and personal care | Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention | |
Secondary | Perception of the intervention | Interview, Study group using Hybrid Assistive Limb (HAL) only. | after 4 weeks of intervention | |
Secondary | Stroke Impact Scale (SIS) | Functioning and disability, Interview | Assessed at 6 months after intervention | |
Secondary | EQ-5D | Health Outcome | Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention |
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