Condition category
Nervous System Diseases
Date applied
09/12/2016
Date assigned
16/12/2016
Last edited
11/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A stroke is a serious condition where the blood supply to a part of the brain is cut off, usually by a blood clot blocking an artery (ischaemic stroke) or a bleed (haemorrhagic stroke). A large proportion of stroke victims suffer from long-term complications depending on the area of the brain that is affected, affecting their ability to speak, think and move. One of the most common complications of a stroke is paralysis (hemiplegia) or weakness (hemiparesis) on one side of the body, especially in the legs. This can make movements such as walking very difficult and so patients need extensive physiotherapy to help them recover. For several decades, traditional physical and occupational therapy programs have been used to help stroke patients learn to walk again. These recoveries are not always successful however and so it is important to find new strategies to enhance post-stroke recovery. Robotic-assisted gait training was introduced as a new treatment to improve walking recovery. It uses either an end-effector (device at the end of a robotic arm, designed to interact with the environment) or exoskeleton (external structure which supports the body underneath) to provide programmable gait (way of walking) training. This study is looking at a new Robotic Gait Training System (RGTS), which is a hybrid of end-effector and exoskeleton. The patient can receive passive stepping exercise under a weight-bearing condition. The aim of this study is to explore the feasibility and safety of this new system to find out if it is more effective than the sitting passive leg motion system (sitting and moving the leg) at helping stroke patients recover their mobility.

Who can participate?
Adults who have had a stoke 10-90 days ago which has caused substantial leg disability that is preventing them from being able to stand or walk independently.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive treatment with RGTS for 30 minutes, once a day for 15 consecutive weekdays. This involves passive leg motion training (like stepping) while wearing the RGTS device (which holds and moves the leg). Those in the second group receive treatment with the sitting passive leg motion system for 30 minutes, once a day for 15 consecutive weekdays. This involves a passive leg motion training (like cycling). At the start of the study and then after three weeks (end of treatment) and three months, participants in both groups have their leg function and abilities assessed.

What are the possible benefits and risks of participating?
Participants may benefit from an improvement to their leg function. There are no notable risks involved with participating.

Where is the study run from?
Shuang Ho Hospital, Taipei Medical University (Taiwan)

When is the study starting and how long is it expected to run for?
July 2015 to January 2019

Who is funding the study?
Wan Fang Hospital, Taipei Medical University (Taiwan)

Who is the main contact?
Dr Yen-Nung Lin

Trial website

Contact information

Type

Scientific

Primary contact

Dr Yen-Nung Lin

ORCID ID

Contact details

Wan Fang Hospital
Taipei Medical University
111 Hsing-Long Road
Section 3
Taipei
116
Taiwan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N201509027

Study information

Scientific title

In stroke patients with significant leg dysfunction, does weight-bearing passive motion exercise, compared to sitting passive motion exercise, facilitate the leg motor recovery?

Acronym

Study hypothesis

The aim of this study is to compare the robotic gait training system (RGTS) with a sitting passive motion exercise to observe the effects on the neurological and functional levels regarding the lower extremities in stroke patients.

Ethics approval

The Joint Institutional Review Board of Taipei Medical University, 04/11/2015, ref: N201509027

Study design

Single-center assessor-blind randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Marked leg dysfunction after stroke

Intervention

The participants are randomly allocated at a 1:1 ratio to one of two study arms.

Arm 1: Participants receive treatment with the robotic gait training system. This involves a passive leg motion training (like stepping) with the RGTS device. The participant receives the training under a weight-bearing condition (ie, the legs bear weight).

Arm 2: Participants receive treatment with the sitting passive leg motion system. This involves a passive leg motion training (like cycling). With this training, the participant is under a non-weight-bearing condition (ie, the legs bear no weight).

Both interventions are delivered in daily 30 minute sessions for 15 consecutive weekdays.

Participants in both groups are followed up post-treatment and then three months later.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Neurological status of legs is assessed using the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE) at baseline, 3 weeks and 3 months.

Secondary outcome measures

1. Postural control is measured using the Postural Assessment Scale for Stroke at baseline, 3 weeks and 3 months
2. Body balance function is measured using the Berg Balance Scale at baseline, 3 weeks and 3 months
3. Activity of daily life is measured using the Barthel Index at baseline, 3 weeks and 3 months
4. Mobility function is measured using the Timed Up and Go test at baseline, 3 weeks and 3 months

Overall trial start date

01/07/2015

Overall trial end date

01/01/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Stroke in the past 10-90 days
2. Display substantial leg disabilities (e.g. a Brunnstrom stage (BS) of I-III in the paretic leg),
3. Unable to stand or walk independently even with orthosis included (e.g. a Functional Ambulation Classification (FAC) of 0-1)
4. Aged 18 years and over

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

60 (30 in each arm)

Participant exclusion criteria

1. Substantial spasticity over the affected leg
2. Severe osteoarthritis,
3. Walking disabilities before the stroke

Recruitment start date

01/01/2016

Recruitment end date

01/09/2018

Locations

Countries of recruitment

Taiwan

Trial participating centre

Shuang Ho Hospital, Taipei Medical University
No.291 Zhongzheng Road Zhonghe District
New Taipei City
235
Taiwan

Sponsor information

Organisation

Wan Fang Hospital, Taipei Medical University

Sponsor details

111 Hsing-Long Road
Section 3
Taipei
116
Taiwan

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Wan Fang Hospital, Taipei Medical University

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results of this study will published on an academic journal.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

01/12/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

11/08/2017: Internal review.