New Technology for Individualised, Intensive Training of Gait After Stroke- Study II

Stroke Clinical Trial

— HAL-RCT-II  

Official title:

New Technology for Individualised, Intensive Training of Gait After Stroke- Phase II Trials, Study II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02545088
• Other study ID #: HAL-RCT-Phase II-Study II
• Status: Completed
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Ambulation Difficulty
• Hemiparesis
• Mobility Limitation
• Paresis
• Stroke

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