Condition category
Injury, Occupational Diseases, Poisoning
Date applied
20/10/2020
Date assigned
29/10/2020
Last edited
28/10/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Core control is essential for carrying out activities of daily living but is very often impaired after a spinal cord injury, hindering functional recovery. This project aims to study the effectiveness of combined arm cycling and standard exercise training in improving trunk function in individuals with a spinal cord injury. It is hoped that the arm cycling exercise will enhance the effectiveness of standard exercise training at improving trunk function in individuals with spinal cord injury.

Who can participate?
Adults (aged 18 years and above) with a stable, chronic cervical or thoracic, incomplete spinal cord injury are eligible to participate in the study. Additional inclusion criteria are to be able to voluntarily pedal the arm bike and to have some residual trunk control.

What does the study involve?
All participants will undertake exercise training for improving trunk control three times a week for 8 weeks. Of these, half of them will undertake an additional arm cycling exercise at home, and the other half will undertake static sitting exercise at home. Neural and functional assessments will be performed at the beginning and after 4 and 8 weeks. A follow-up assessment will be carried out at 8 weeks after completing the intervention.

What are the possible benefits and risks of participating?
Participants will benefit from the arm cycling exercise and rehabilitation training by directly exercising muscles of the arms and the core, thereby improving mobility and strength. Participants may experience muscle soreness of the arms and shoulders as a result of 30 minutes of arm cycling. However, the muscle soreness should last no longer than 3 days and can be eased by gentle stretching of the muscles. Some participants may experience a mild headache after the neural assessment. Taking a painkiller before the assessment or resting after the assessment usually can release the headache effectively.

Where is the study run from?
The study is run by a research team at the University of Birmingham in collaboration with the Midland Centre for Spinal Injuries at the Robert Jones and Agnes Hunt Orthopaedic Hospital NHS FT, and with the National Spinal Injuries Centre, Stoke Mandeville Hospital Buckinghamshire Healthcare NHS Trust (UK)

When is the study starting and how long is it expected to run for?
January 2021 to January 2024

Who is funding the study?
The INSPIRE Foundation (UK)

Who is the main contact?
Dr Chloe Chiou
s.chiou@bham.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Shinyi Chiou

ORCID ID

http://orcid.org/0000-0002-4200-5243

Contact details

School of Sport
Exercise
and Rehabilitation Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 5315
s.chiou@bham.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 289841

Study information

Scientific title

Functional activity of upper extremities to improve trunk function after spinal cord injury

Acronym

Study hypothesis

It is hypothesised that SCI participants undertaking the combined intervention will increase the ability to recruit trunk muscles for postural stability to a greater extent compared to those undertaking the therapeutic exercise training alone.

Ethics approval

Approval pending

Study design

Two-arm randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

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

Condition

Stable, lower cervical or upper thoracic, incomplete spinal cord injury

Intervention

Participants will be randomized into one of the two groups: the experimental group and the control group using minimisation methods ensuring balance in prognostic factors (e.g. level of injury, years since injury) between groups. All participants will receive standard exercise training focusing on improving trunk control and postural stability 3 times per week for 8 weeks. Participants in the experimental group will undertake arm cycling exercise at home using a stationary arm bike provided by the research team for 30 minutes, 5 days per week, for 8 weeks. Participants in the control group will be instructed to practise static sitting without back support for the same amount of time. After completing the intervention, all participants will be followed up for 8 weeks to monitor whether the interventional effects outlast or not. Neurophysiological and functional assessments will be performed during the course of the intervention to monitor improvements in trunk control. Participants will stay in the trial for 16 weeks in total (8 weeks of intervention and 8 weeks of follow-up).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Dynamic sitting balance assessed by multidirectional reach test at baseline, 4, 8 and 16 weeks

Secondary outcome measures

1. Neuromuscular and corticospinal function of the trunk muscles measured using non-invasive transcranial magnetic stimulation at baseline, 4, 8 and 16 weeks
2. Mobility measured using time of 3-meter walking or wheelchair transfer at baseline, 4, 8 and 16 weeks
3. Pressure relief measured using a force plate at baseline, 4, 8 and 16 weeks
4. Trunk control measured using trunk impairment scale at baseline, 4, 8 and 16 weeks
5. Function of upper extremities measured using a dynamometer and the Action Research Arm Test at baseline, 4, 8 and 16 weeks

Overall trial start date

04/01/2021

Overall trial end date

03/01/2024

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

SCI participants will be included if they have:
1. A stable, lower cervical or upper thoracic, incomplete spinal cord injury.
2. Ability to voluntarily move the elbow to operate the arm bike.
3. Visible motor evoked potentials (MEPs) in erector spinae (ES) muscles induced by transcranial magnetic stimulation (TMS). This is to ensure changes in corticospinal function are measurable

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

Participants will be excluded if they meet the criteria for exclusion for the use of TMS (Rossi et al., 2011):
1. Metal implants, cardiac pacemaker, history of epilepsy or fits, previous brain injury, neurosurgery of the brain, neurological disorders other than spinal cord injury, psychological disorders, actively taking antidepressant or other neuromodulatory drugs
2. Participants are pregnant or breastfeeding
3. Participants are under the age of 18

Recruitment start date

03/05/2021

Recruitment end date

02/05/2023

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Trial participating centre

Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Midland Centre for Spinal Injuries The Robert Jones and Agnes Hunt Orthopaedic Hospital NHSFT
Oswestry
SY10 7AG
United Kingdom

Trial participating centre

The National Spinal Injuries Centre
NSIC, Stoke Mandeville Hospital Buckinghamshire Healthcare NHS Trust
Aylesbury
HP21 8AL
United Kingdom

Sponsor information

Organisation

University of Birmingham

Sponsor details

Egbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)1214145315
s.chiou@bham.ac.uk

Sponsor type

University/education

Website

https://www.birmingham.ac.uk/index.aspx

Funders

Funder type

Charity

Funder name

Inspire Foundation

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. The researchers are planning to publish the study protocol in a peer-reviewed journal
2. Results will be published in peer-reviewed journals and presented at major conferences in both the scientific and clinical fields

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from the principal investigator Dr Shinyi Chiou (s.chiou@bham.ac.uk). Neurophysiological and behavioural data that are fully anonymous will be accessible for research/academic purposes after the data are analysed and published in peer-reviewed journals (estimated January 2025 for 10 years, per University Data storage policy). Data will be shared as a spreadsheet and only for non-commercial use.

Intention to publish date

04/01/2024

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

28/10/2020: Trial's existence confirmed by the Inspire Foundation.