A Comparison Between the Exoskeleton Hybrid Assistive Limb and Conventional Gait Training Early After Stroke

NCT02410915 | Completed

• 1 other identifier: 2013/1807-31/2
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Overall aim is to evaluate HAL for gait training early after stroke and the effect of HAL on short- and long-term functioning, disability and health compared to conventional gait training as part of an inpatient rehabilitation program early after stroke.

Conditions

Stroke; Gait, Hemiplegic; Ambulation Difficulty; Hemiparesis

Keywords

Rehabilitation; Robotics

Outcome Measures

Primary Outcomes (1)

• Change in Functional Ambulation Categories (FAC)

  Level of independence in walking, range 0-5

  Assessed at baseline, after 4 weeks of training and 6 months after stroke

Other Outcomes (10)

• Change in Gait Deviation Index (GDI)

  After 4 weeks of training and 6 months after stroke

• Change in GDI-kinetic.

  After 4 weeks of training and 6 months after stroke

• Change in Barthel Index

  Assessed at baseline, after 4 weeks of training and 6 months after stroke

Study Arms (2)

Study Group

EXPERIMENTAL

Intervention: Hybrid Assistive Limb (HAL); gait training in combination with conventional training. Training with the exosceleton Hybrid Assistive Limb (HAL) is performed in 1 session per day, 4 days per week during 4 weeks. Time for each session is individualised but does not exceed 60 minutes/session (effective time). Training with HAL is performed in combination with body-weight support system and on a treadmill. The training program is performed by 2 physiotherapists, who have been trained in the HAL method.

Device: Hybrid Assistive Limb (HAL); gait training

Control Group

ACTIVE COMPARATOR

Intervention: Conventional gait training is individualized and performed according to current practice (approximately 30-60 minutes/session, 5 days a week) and may include standing, weight shifting, stepping, over ground walking with assistance and/or assistant devices as well as the use of a treadmill and body weight support. Conventional gait training is offered to both study groups.

Other: Control Group; Conventional gait training

Interventions

Hybrid Assistive Limb (HAL); gait training DEVICE

Training with HAL is performed in 1 session per day, 4 days per week during 4 weeks. Time for each session is individualised but does not exceed 60 minutes/session (effective time). Training with HAL is performed in combination with body-weight support system and on a treadmill. The training program is performed by 2 physiotherapists, who have been trained in the HAL method.

Also known as: Hybrid Assistive Limb (HAL)

Study Group

Control Group; Conventional gait training OTHER

Conventional gait training is individualized and performed according to current practice (approximately 30-60 minutes/session, 5 days a week) and may include standing, weight shifting, stepping, over ground walking with assistance and/or assistant devices as well as the use of a treadmill and body weight support. Conventional gait training is offered to both study groups.

Control Group

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• less than 8 weeks since stroke onset; inability to walk independently due to lower extremity paresis (i.e. FAC score 0-1), able to sit on a bench with or-without supervision at least five 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.

You may not qualify if:

• contracture restricting gait movements at any lower limb joint; cardiovascular or other somatic condition incompatible with intensive gait training; and severe, contagious infections.

Sponsors & Collaborators

• Danderyd Hospital: lead
• University of Tsukuba: collaborator

Study Sites (1)

Department of Rehabilitation Medicine, Danderyd Hospital

Danderyd, Stockholm County, 18288, Sweden

Location

Related 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.

  PMID: 24890413 BACKGROUND

• Wall A, Palmcrantz S, Borg J, Gutierrez-Farewik EM. Gait pattern after electromechanically-assisted gait training with the Hybrid Assistive Limb and conventional gait training in sub-acute stroke rehabilitation-A subsample from a randomized controlled trial. Front Neurol. 2023 Oct 11;14:1244287. doi: 10.3389/fneur.2023.1244287. eCollection 2023.

  PMID: 37885482 DERIVED

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic; Mobility Limitation; Paresis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jörgen Borg, Professor

  Department of Rehabilitation medicine, Danderyd Hospital, Karolinska Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Reg. Physiotherapist

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: April 8, 2015
• Study Start: February 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2017
• Last Updated: May 18, 2017

Record last verified: 2017-05

Locations

SE (1)