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

NCT02545088 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-12-19

No results posted yet for this study

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.

Conditions

  • Stroke
  • Ambulation Difficulty
  • Hemiparesis

Interventions

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.

OTHER

2nd control group

The 2nd control group will not receive an intervention.

Sponsors & Collaborators

  • University of Tsukuba

    collaborator OTHER

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Umeå University

    collaborator OTHER

  • Danderyd Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2019-09-30
Completion
2019-10-31

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02545088 on ClinicalTrials.gov