NCT02545205

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?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
2.3 years until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

February 13, 2023

Status Verified

April 1, 2018

Enrollment Period

8 months

First QC Date

August 24, 2015

Last Update Submit

February 9, 2023

Conditions

StrokeAmbulation DifficultyHemiparesis

Keywords

RehabilitationRobotics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • 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

  • Albert's test

    Assessed at baseline

  • 2 Minutes Walk Test (MWT)

    Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention

  • Berg Balance scale

    Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention

  • +4 more secondary outcomes

Study Arms (2)

Hybrid Assistive Limb (HAL)

EXPERIMENTAL
Device: Hybrid Assistive Limb (HAL)

Conventional gait training

ACTIVE COMPARATOR
Other: Conventional gait training

Interventions

Hybrid Assistive Limb (HAL)DEVICE

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).

Hybrid Assistive Limb (HAL)
Conventional gait trainingOTHER

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.

Conventional gait training

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Rehabilitation Medicine, Danderyd Hospital

Danderyd, Stockholm County, SE-18288, Sweden

Location

Sahlgrenska University Hospital

Gothenburg, SE-413 46, 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: 24890413BACKGROUND

  • 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.

    PMID: 25859191BACKGROUND

MeSH Terms

Conditions

StrokeMobility LimitationParesis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurologic Manifestations

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

August 24, 2015

First Posted

September 9, 2015

Study Start

January 1, 2018

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

February 13, 2023

Record last verified: 2018-04

Locations

SE(2)