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Trial registered on ANZCTR

Registration number

ACTRN12616001283460

Ethics application status

Approved

Date submitted

2/08/2016

Date registered

12/09/2016

Date last updated

11/07/2017

Type of registration

Retrospectively registered

Titles & IDs

Public title

The efficacy of gait training using a body weight support treadmill and visual biofeedback in patients with subacute stroke: a randomized controlled trial

Scientific title

The efficacy of gait training using a body weight support treadmill and visual biofeedback in patients with subacute stroke: a randomized controlled trial

Secondary ID [1]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

hemiparesis

gait limitations

gait assymetry

body balance

stroke

Condition category

Condition code

Stroke

Ischaemic

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The study will be conducted with selected stroke patients in subacute period previously treated in the Rehabilitation Clinic.
Participants who meet eligibility requirements will be randomly divided into the control and the study group. Study group patients will be enrolled in treadmill training with partial body weight support (PBWS) and real time visual feedback. The treadmill software displays a real time visualization of patient’s feet placement and the area in which the next step should be placed to maintain the symmetry of patient’s gait. The gait velocity and the required step length will be adjusted to the patient’s physical abilities. The amount of body weight support will not exceed 30% of the patient’s body weight. The control group members will be trained on the same treadmill with exactly the same body weight support system.
Treadmill training in both groups will be conducted by a physiotherapist who is not participating neither in a basic survey nor in a control test. Training parameters for each patient will be individually tailored by the physiotherapist. Participation in the training is confirmed in medical records.
Both group’s sessions will be conducted Monday to Friday ( 5 days) for 3 weeks. Each session will last 30 minutes.
Patients will implement a standard rehabilitation program but no other equipment as Lokomat or exoskeleton Ekso GT. Standard program is sent by rehabilitation team and is not administered as part of this study
All patients qualified for the study will practice on the treadmill as well as participate in the rehabilitation program set up by a physiotherapist’s team.
Each patient will train for a maximum 90 minutes a day. Patients will be assessed before and after treadmill gait training. Patients will stay in Rehabilitation Clinic for 5 to 7 weeks. All exercises including treadmill trainings will be prepared by the experienced physiotherapists, working in the Rehabilitation Clinic.

Intervention code [1]

Treatment: Devices

Intervention code [2]

Rehabilitation

Comparator / control treatment

Members of the control group will undergo the training on the same treadmill with exactly the same PBWS system as the study group. The control group will not be provided with the visual feedback software. The gait speed will be adjusted to the patient’s individual abilities. The amount of body weight support will not exceed 30% of patient’s body weight. Treadmill gait training time- 30 minutes. Number of trainings- 15, 3 weeks (form Monday to Friday). Alongside the treadmill training, the control group will also undergo a daily rehabilitation program, including 90 minutes of excersise therapy. Patients will stay in Rehabilitation Clinic from 5 to 7 weeks.

Control group

Active

Outcomes

Primary outcome [1]

Temporal and spatial parameters of gait assessed by 3D motion analysis system (BTS Smart, BTS Bioengineering, Milan, Italy)

Timepoint [1]

Baseline, after 3 weeks of treatment

Primary outcome [2]

Kinematic parameters of gait assessed by 3D motion analysis system (BTS Smart, BTS Bioengineering, Milan, Italy)

Timepoint [2]

Baseline, after 3 weeks of treatment

Primary outcome [3]

Changes in gait symmetry ratio. The symmetry ratio will be calculated on the basis of analysis of the kinematic, temporal and spatial gait parameters for the right and left lower limb. A symmetry ratio will be calculated for all analyzed parameters. The left and right average values of swing time and stance time, step length, total hip and knee range of motion and intra-limb ratio of swing: stance time (SW/ST) a ratio with the largest value in the numerator so that all values for every individual were >1.0. A ratio value of 1.0 denotes perfect symmetry.

Timepoint [3]

Baseline and after 3 weeks of treatment

Secondary outcome [1]

Change in gait speed assessed in the 10 meter test.

Timepoint [1]

Baseline, after 3 weeks of treatment

Secondary outcome [2]

Change in muscular activity assessed by superficial EMG (Noraxon TELEMYO DTS,Noraxon U.S.A. Inc.)

Timepoint [2]

Baseline, after 3 weeks of treatment

Secondary outcome [3]

Change in functional capacity assessed using Barthel index

Timepoint [3]

Baseline, after 3 weeks of treatment

Secondary outcome [4]

Balance, assessed with postural sway on portable force plate (AMTI BP/OR). Analysed will be the length of the path of movement of COP (mm), the surface area of movement of COP (mm2), COP range scalar in anteroposterior (A-P) direction and COP range scalar in mediolateral (M-L) (mm) direction.

Timepoint [4]

Baseline, after 3 weeks of treatment

Secondary outcome [5]

Dynamic balance will be assessed by the Timed Up and Go Test

Timepoint [5]

Baseline, after 3 weeks of treatment

Eligibility

Key inclusion criteria

First-time ischemic stroke in subacute phase (less than 60 days from stroke)
Unilateral hemiplegia
Independent gait
Brunnstrom Motor Recovery Stage (leg) from 2 to 3 stages

Minimum age

18 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Second or another stroke incydent
severe heart insufficiency and uncontrolled arterial hypertension
cognitive disorders impairing the understanding of and ability to follow instructions
visual field disturbances caused by a stroke or other visual disturbances impairing normal vision
orthopedic disorders significantly affecting the gait of participants
Untreated deep vein thrombosis

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

22/02/2016

Date of last participant enrolment

Anticipated

30/12/2016

Actual

30/12/2016

Date of last data collection

Anticipated

Actual

30/12/2016

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Poland

State/province [1]

Podkarpackie

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Rzeszow

Address [1]

Aleja Rejtana 16c
35-959 Rzeszow

Country [1]

Poland

Primary sponsor type

Individual

Name

Mariusz Druzbicki

Address

University of Rzeszow
Institute of Physiotherapy
Warszawaka 26a
25-305 Rzeszow

Country

Poland

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Ethical Committee of University of Rzeszow

Ethics committee address [1]

Medical Faculty
Al. mjr. W. Kopisto 2 a
35-310 Rzeszow

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

02/11/2015

Approval date [1]

02/02/2016

Ethics approval number [1]

17/02/2016

Summary

Brief summary

Brain strokes are one of the main causes of permanent impairment. The main symptoms of stroke are hemiparesis, muscle tension disorders, balance and coordination impairment, cognitive functions and communicative disorders. Restoration of patient’s gait is one of the primary targets of rehabilitation after stroke. Although 80% of stroke survivors regain the ability of independent walking, their gait is often impaired and limited. Disorders mainly lower the gait speed and the covered distance, they also affect the stability of gait. Among many patients the asymmetrical walking pattern is observed among time and space-related parameters. In rehabilitation of stroke patients many different techniques and devices are used, treadmills, partial body weight support systems and robots are commonly used. The efficacy of gait training is increased in systems providing real time feedback (gait parameters), the method using acoustic and visual feedback is very efficient and important. The use of treadmill and PBWS facilitates patient’s moves, it also facilitates to perform a full gait cycle (similar pattern to the natural one) by patient, it allows to increase the gait speed, covered distance, what increases the efficacy of motoric training. The real time, visual feedback about the symmetry and the length of patient’s step allows him to adjust his gate properly and learn the symmetrical walking pattern. 
The aim of this study is to asses the gait training with PBWS treadmill and visual feedback  among patients during subacute period after stroke. The assumed hypothesis is that gait training on a treadmill with PBWS and visual feedback facilitates the reconstruction of the symmetrical gait in comparison to patients training on a treadmill with PBWS, but without visual feedback.
The study will be conducted on the clinical rehabilitation ward of the Clinical Provincial Hospital in Rzeszów, Poland. Patients recruited for the study will be stroke survivors, that had suffered from brain stroke three weeks before they were recruited for the study. Gait training will be performed using the Gait Trainer 3 treadmill with partial body weight support system (provided by Biodex). The treadmill software enables a real time feedback, informing the patient about the placement of his feet and the correct area they should be placed in order to make the patient’s step length symmetrical.
Patients qualified for the study will be randomly divided into two groups. The study group will be training on a treadmill with real time visual feedback and the control group will use the same treadmill, but without visual feedback provided. Each patient is going to undergo the training every day (from Monday to Friday) for three weeks. One training session will last for 30 minutes.
Qualifications for the study will be performed by experienced physiotherapists. Initial and control examinations will be performed by the team member, who is not participating in patient’s training. Along the treadmill gait training, patients will be undergoing the rehabilitation program, set by the physiotherapeutic team.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Mariusz Druzbicki

Address

University of Rzeszow
Institute of Physiotherapy
Warszawska st. 26a
35-205 Rzeszow

Country

Poland

Phone

+48178721941

Fax

+48178721930

[email protected]

Contact person for public queries

Name

Mariusz Druzbicki

Address

University of Rzeszow
Institute of Physiotherapy
Warszawska st. 26a
35-205 Rzeszow

Country

Poland

Phone

+48178721941

Fax

+48178721930

[email protected]

Contact person for scientific queries

Name

Mariusz Druzbicki

Address

University of Rzeszow
Institute of Physiotherapy
Warszawska st. 26a
35-205 Rzeszow

Country

Poland

Phone

+48178721941

Fax

+48178721930

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The efficacy of gait training using a body weight support treadmill and visual biofeedback in patients with subacute stroke: A randomized controlled trial.	2018	https://dx.doi.org/10.1155/2018/3812602

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically