AzTrials
AzTrials

Cerebrovascular AccidentBWSGRNCT01094470

Body Weight Support Training on Ground Level

A study testing Body weight support system on ground level in people with Cerebrovascular Accident and Cerebrovascular Stroke, run by Universidade Federal de Sao Carlos.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study was to investigate the effects of gait training on ground level with partial body weight support (BWS)in individuals with stroke during overground walking with no BWS. Read more about this study

Who is it for?
Any age
What is being tested?
Body weight support system on ground level
Type of treatment
Medical device
How many people
12 participants
Where
No sites listed yet
Study dates
Aug 2007to Apr 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Elapsed time since stroke longer than one year
  • Ability to walk approximately 10 m with or without assistance
  • Spasticity classified as below level 3 by the Modified Ashworth Scale

Who cannot join

  • Presence of clinical signs of heart failure (New York Heart Association), arrhythmia, or angina pectoris
  • Absence of spasticity
  • Presence of orthopedic or other neurological diseases that compromised gait
  • Presence of severe cognitive or communication impairments

About this study

Official title: Ground-level Partial Body Weight Support Gait Training for Individuals With Chronic Stroke

The purpose of this study was to investigate the effects of gait training on ground level with partial body weight support (BWS)in individuals with stroke during overground walking with no BWS.

Read the detailed description

Individuals were mechanically supported on a BWS system as they walked on ground level. All individuals started the training with 30% of body weight unloading and after three weeks, this percentage was reduced to 20% for the remainder of the six-week training period. The criterion used to reduce the percentage of BWS was the individual's ability to maintain alignment of the trunk and to transfer the weight to and from the paretic limb during gait. Individuals' body mass was measured weekly to ensure the appropriate percentage of body weight unloading.

During the training sessions, a physical therapist encouraged the individuals to walk as fast as possible, and feedback was provided in order to improve gait performance, such as vertical alignment of the trunk, symmetric limb weight distribution, and proper movement of the lower limbs. Heart rate and blood pressure were observed at beginning and end of each session, and when the patients reported any symptoms of discomfort during the session. Rest periods were allowed during the training sessions according to individual need.

All individuals were submitted to gait training sessions of 45 minutes, three times a week, on alternating day during six weeks, completing a total of 18 sessions. None of them were given any other type of physical intervention or conventional gait training, stretching, muscle strengthening or endurance exercise while participating in this study.

In order to verify the effects of the described gait training, individuals were assessed before and after gait training program, walking freely at self-selected comfortable speed along a 10 m walkway six times. They were videotaped by four digital cameras (AG-DVC7P, Panasonic) at 60 Hz, which were positioned bilaterally in order to allow simultaneous kinematics measurement of paretic and nonparetic limbs in either direction of motion (from left to right and vice-versa). During the evaluation, individuals were not allowed to use any assistive device, and they walked with the physical therapists' assistance to keep balance, when necessary.

Passive reflective markers were placed on the nonparetic and paretic sides of the body at the following anatomical locations: head of the fifth metatarsal, lateral malleolus, lateral epicondyle of the femur, greater trochanter, and acromion, in order to define the foot, shank, thigh, and trunk segments, respectively. The digitalization and the reconstruction of all markers were performed using Ariel Performance Analysis System - APAS (Ariel Dynamics, Inc.) software, and filtering and posterior analyses were performed using Matlab software (MathWorks, Inc. - Version 6.5). Reconstruction of the real coordinates was performed using the direct linear transformation (DLT) procedure.

Being tested
Body weight support system on ground level
Keywords
gait, ambulation, kinematics
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Body weight support system on ground levelDevice

    Also called partial body weight support, body weight unloading, body weight alleviation

    Gait training with body weight support on ground level with sessions of 45 minutes, three times a week, on alternating day during six weeks, completing a total of 18 sessions.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean walking speed

    Mean walking speed was evaluated before and after the training period of six weeks

    Measured: Six weeks

Secondary outcomes (1)
  1. Step length and step symmetry

    Step length and step symmetry were evaluated before and after the training period of six weeks

    Measured: Six weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2010 (estimated)
  2. Study startAug 2007
  3. Primary completionDec 2007
  4. Study completionApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01094470
Sponsor's protocol ID
BWS-BARELA
Acronym
BWSGR
Status last verified
Jul 2006
First submitted
25 Mar 2010
Last updated
29 Mar 2010
Results posted
No
Data monitoring committee
No

Publications

  • Sousa CO, Barela JA, Prado-Medeiros CL, Salvini TF, Barela AM. The use of body weight support on ground level: an alternative strategy for gait training of individuals with stroke. J Neuroeng Rehabil. 2009 Dec 1;6:43. doi: 10.1186/1743-0003-6-43.

    PubMed 19951435

Questions about this trial

What is this clinical trial studying?

A study testing Body weight support system on ground level in people with Cerebrovascular Accident and Cerebrovascular Stroke, run by Universidade Federal de Sao Carlos.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean walking speed (time frame: Six weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01094470, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2010; AzTrials last refreshed its copy on 27 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in