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

Stroke Clinical Trial

— HAL-RCT-II  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02545205
• Other study ID #: HAL-RCT-Phase II-Study I
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: September 1, 2018

Study information

• Verified date: April 2018
• 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 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?

Description:

Patients will be randomized using a block randomization by a nurse, who is not otherwise involved in the study, into either 1) HAL training in addition to the conventional program or 2) evidence based conventional gait training only. The block randomization will be designed so that an even number of patients with left and right sided hemiparesis will have been included in each group at the end of the study.

Conventional training (including gait practice) will be performed according to current best practice (approximately 30-60 min per day, 5 days per week) and may include stepping, weight shifting, over ground walking as well as the use of a treadmill with/without body weight support (BWS).

HAL training will be performed 4 days a week for 4 weeks (i.e. 16 sessions) with the single-leg version of HAL, primarily by use of the voluntary HAL-mode (CVC mode), on a treadmill with BWS. The therapist(s) educated in the HAL method will optimize the HAL settings for each individual during each session, in order to obtain a symmetrical gait pattern as close to normal gait as possible.

Outcomes The primary outcome will be changes in the FAC-score during the intervention. FAC assesses activity in terms of independence in walking on a six-grade-ordinal-scale ranging from non-functional walking to independent walking outside. During the intervention assessments with the FAC will be performed weekly by the patients' physiotherapist responsible for conventional rehabilitation. This therapist will otherwise not be involved in the study.

Secondary outcomes include aspects of body functions assessed by use of the NIH Stroke Scale, Albert's test, Fugl-Meyer Assessment(FMA-LE) and the Modified Ashworth Scale for the lower extremities.

Activities and Participation will be assessed by use of Functional Ambulation Categories, 2 minutes walk test in self-preferred speed, Berg Balance Scale, Barthel Index and EQ5D.

Patients' perception of training will be assessed by a study specific questionnaire.

Adverse events (such as irritated skin, pain, falls) will be documented continuously in the study protocol according to a specific study form.

Assessments will be performed 1) before and 2) after the intervention with 3) a follow up at 6 months.

Recruitment information / eligibility

• 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.

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, 4 days/week during 4 weeks. Time for each session is individualised but does not exceed 60 minutes/session (effective walking time with HAL).

Other:
• Conventional gait training
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.

Locations

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

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, 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

Outcome

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