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

Not Applicable

Terminated

• Conditions: Stroke; Hemiparesis; Ambulation Difficulty
• Interventions: Other: Conventional gait training; Device: Hybrid Assistive Limb (HAL)

• Registration Number: NCT02545205
• Lead Sponsor: Danderyd Hospital

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 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?

Detailed 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.

Study Timeline

• Study First Submitted: 2015-08-24
• Study First Submitted QC: 2015-09-08
• Study First Posted: 2015-09-09
• Study Start: 2018-01-01
• Status Verified: 2018-04
• Primary Completion: 2018-09-01
• Study Completion: 2018-09-01
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional gait training	Conventional gait training	-
Hybrid Assistive Limb (HAL)	Hybrid Assistive Limb (HAL)	-

Primary Outcome Measures

Name	Time	Method
Change in Functional Ambulation Categories (FAC)	Assessed at baseline, weekly, after 4 weeks of intervention and at 6 months post intervention	Level of independence in walking, range 0-5

Secondary Outcome Measures

Name	Time	Method
Objectively quantify the impairment caused by a stroke, using the National Institutes of Health Stroke Scale (NIHSS)	At baseline
Fugl-Meyer for Lower extremities	Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention	Sensory and motor function in lower extremities
2 Minutes Walk Test (MWT)	Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention	Walking
EQ-5D	Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention	Health Outcome
Albert's test	Assessed at baseline	Spatial negelct
Berg Balance scale	Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention	Balance
Barthel Index	Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention	Independence in mobility and personal care
Perception of the intervention	after 4 weeks of intervention	Interview, Study group using Hybrid Assistive Limb (HAL) only.
Stroke Impact Scale (SIS)	Assessed at 6 months after intervention	Functioning and disability, Interview

Trial Locations

Locations (2)

Department of Rehabilitation Medicine, Danderyd Hospital; 🇸🇪 Danderyd, Stockholm, Sweden

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden