Condition category
Injury, Occupational Diseases, Poisoning
Date applied
10/08/2018
Date assigned
22/08/2018
Last edited
12/12/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims
In the majority of spinal cord injury (SCI) patients who retain some walking ability, movement is often limited to the confines of their homes or short distances, and patients are often dependent upon the assistance of devices or their caregivers. Therefore, one of the main focuses of rehabilitation for these patients is the recovery of the ability to walk well. Good walking quality includes walking fast and walking symmetrically. It is possible to obtain quantitative data about the walking ability of these patients, which can be used to help with recognition of the underlying causes and development of pathological gaits (walking abnormalities). This study aims to use a device called the Footscan plantar pressure system to collect this walking data to determine the differences in walking quality between SCI patients and healthy subjects.

Who can participate?
Healthy adults with a spinal cord injury

What does the study involve?
Participants will be asked to walk in bare feet upon the Footscan platform at a comfortable speed for at least 2 times to familiarise themselves with the device and then 3 times to test their walking quality after resting.

What are the possible benefits and risks of participating?
The benefit of participating in this trial is that patients will receive a report about their walking quality (plantar pressure and gait). There are no known risks to participants taking part in this study.

Where is the study run from?
Rehabilitation Department of Shengjing Hospital of China Medical University. (China)

When is the study starting and how long is it expected to run for?
October 2013 to March 2017

Who is funding the study?
Shengjing Hospital of China Medical University (China)

Who is the main contact?
Dr Xiangnan Yuan
yuanxn@sj-hospital.org

Trial website

Contact information

Type

Public

Primary contact

Dr Xiangnan Yuan

ORCID ID

Contact details

No.36
Sanhao Street
Heping District
Shenyang
110004
China
+86-18940256238
yuanxn@sj-hospital.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.0

Study information

Scientific title

The effects of the Footscan plantar pressure plate system on walking quality variables between spinal cord injury patients and healthy subjects

Acronym

Study hypothesis

Compared with healthy subjects, there will be a difference in variables of gait and an asymmetry of gait quality in spinal cord injury patients, including step length and the variables of plantar pressure.

Ethics approval

Clinical Research Ethics Committee of Shengjing Hospital of China Medical University, 13/08/2015, No. 2015PS54J

Study design

Observational prospective cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Spinal cord injury

Intervention

The subjects were asked to walk in bare feet upon the footscan platform at their comfortable speed. Each subject undertook at least 2 practice walks along the plate walkway in order to familiarize themselves with, and hence feel at ease with, the experimental process. Following an adequate recuperation period, each subject was asked to walk in bare feet upon the footscan platform at their comfortable speed for at least 3 successful trials. Subjects reporting fatigue were permitted to rest for a minimum of 2 minutes between trials.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Walking speed, measured through participants walking on the the Footscan platform at their comfortable speed for at least 3 successful trials on the day of participation.

Secondary outcome measures

The following were measured on the day of participation by participants walking on the the Footscan platform at their comfortable speed for at least 3 successful trials:
1. Stride time in seconds
2. Stride length in metres
3. Stance time in seconds
4. Step length in metres
5. Peak plantar pressure in Newtons per cm²
6. Impulse in Newtons per second
7. Maximum force in Newtons
8. Contact area percentage

Overall trial start date

01/10/2013

Overall trial end date

01/03/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Spinal cord injury group:
1. Complete spinal cord injury (SCI) according to American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS)
2. Capacity for independent walking, with or without mechanical support, for a minimum of 15 minutes

Healthy subjects:
1. None of the aforementioned conditions
2. Matching age (± 5 years) and sex to participants in SCI group

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

51

Participant exclusion criteria

Spinal cord injury group:
1. Severe spasticity of the lower extremity muscles, rated as greater than or equal to 2 on the Modified Ashworth Scale (MAS)
2. Muscle or joint pain with an intensity rating of greater than 5 out of 10 on a numerical scale
3. Presence of cognitive or behavioural disorders
4. Spinal or lower extremity deformities, such as scoliosis, kyphosis or equinovarus
5. Clinical instability

Healthy subjects:
1. Muscle or joint pain of low extremities or spine
2. Presence of cognitive disorders
3. Flat foot
4. Cavus foot
5. Abnormal gait

Recruitment start date

01/08/2015

Recruitment end date

01/08/2016

Locations

Countries of recruitment

China

Trial participating centre

Shengjing Hospital of China Medical University
No.36, Sanhao Street, Heping District
Shenyang
110004
China

Sponsor information

Organisation

Shengjing Hospital of China Medical University

Sponsor details

No.36
Sanhao Street
Heping District
Shenyang
110004
China
86-024-96615
shengjing@sj-hospital.org

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

Funder name

the New Technique Project of Shengjing Hospital of China Medical University, China, No. 117

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from Xiangnan Yuan (e-mail is yuanxn@sj-hospital.org). Plantar pressure data will become available after the study results are published and will be available for 1 year.

Intention to publish date

Participant level data

Available on request

Basic results (scientific)

Publication list

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30531020

Publication citations

Additional files

Editorial Notes

12/12/2018: Publication reference added.