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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02545088
Other study ID # HAL-RCT-Phase II-Study II
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2015
Est. completion date October 2019

Study information

Verified date December 2020
Source Danderyd Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date October 2019
Est. primary completion date September 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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).

Study Design


Intervention

Device:
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.
Other:
1st control group
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
The 2nd control group will not receive an intervention.

Locations

Country Name City State
Sweden Department of Rehabilitation Medicine, Danderyd Hospital Danderyd Stockholm

Sponsors (4)

Lead Sponsor Collaborator
Danderyd Hospital Sahlgrenska University Hospital, Sweden, Umeå University, University of Tsukuba

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Nilsson A, Vreede KS, Häglund 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Fugl Meyer Scale for lower extremities Sensory and motor function in lower extremities Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Secondary Modified Ashworth Scale Spasticity Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Secondary Spasticity measured with Neuroflexor foot module Spasticity Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Secondary Berg Balance Scale Balance Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Secondary 10 meters walk test Walking Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Secondary 2 minutes walk test Walking Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Secondary Functional Ambulation Categories Walking Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Secondary Borg Rating of Perceived Exertion Scale (RPE) Interview Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Secondary Montreal Cognitive Assessment Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Secondary Hospital anxiety and Depression Scale Interview Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Secondary Barthel Index Independence in mobility and personal care Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Secondary Stroke Impact Scale Functioning and disability, Interview Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Secondary Physical activity in everyday life using SenseWear Registers physical activity in everyday life Assessment at baseline, after 3 weeks of intervention, after 6 weeks of intervention, 6 and 12 month post intervention
Secondary Objectively quantify the impairment caused by a stroke, using the National Institutes of Health Stroke Scale (NIHSS) Stroke severity Assessment at baseline
Secondary Modified Ranking Scale Interview Assessment at baseline
Secondary Body Mass Index Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Secondary Weight Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Secondary Height Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Secondary Blood pressure Registered in everyday life Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Secondary HbA1c Blood test Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Secondary Plasma lipid profile Blood test Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Secondary Perception of the intervention Interview. Study group using Hybrid Assistive Limb (HAL) only. after 6 weeks of intervention
Secondary Smoking Interview Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Secondary Alcohol Interview Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Secondary Drug use From medical records Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Secondary Health care consumption From County Council 12 month post intervention
Secondary Stroke type and localization From medical records At baseline
Secondary Dysexecutive Questionnaire Filled in by significant other At baseline
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