Improving upper limb movement after spinal cord injury with a wearable device
| ISRCTN | ISRCTN15025040 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15025040 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Protocol Wearable Device clinical study SCI v4 |
| Sponsor | Newcastle University |
| Funder | International Spinal Research Trust |
- Submission date
- 01/07/2021
- Registration date
- 07/07/2021
- Last edited
- 18/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Many spinal cord injury (SCI) survivors find that they have an imbalanced weakness in the upper limb: while flexor muscles regain considerable strength after the injury, the extensors such as triceps remain permanently weak. In the Baker group in Newcastle University, we have developed a novel wearable device which can deliver paired stimuli for long periods while a person goes about their normal everyday activities. We have shown that this device can enhance the control of upper limb muscles. In stroke survivors, we have shown that applying this device to extensor muscles can produce a significant improvement in arm and hand function. In this study, we will carry out a clinical trial to test whether the device can also enhance movement in SCI survivors.
Who can participate?
Individuals attending the Neurokinex community gyms with chronic spinal cord injury if they fulfil our Inclusion and Exclusion Criteria.
What does the study involve?
Each participant will receive two different intervention protocols (device, control) for one month each. Participants are asked to wear the device for at least four hours each day for 4 weeks. At baseline, after 4 weeks and after 8 weeks, several electrophysiological measurements will be taken. These include electromyography recordings (EMG) from triceps (including maximal contraction), responses to transcranial magnetic stimulation (TMS), reaction time tasks, reaching tasks and the Capabilities of Upper Extremity Questionnaire.
What are the possible benefits and risks of participating?
Application of the same protocol to the forearm extensor muscles of stroke survivors produced a small but significant improvement in upper limb function. SCI participants could possibly benefit from a similar improvement in upper limb function of the stimulated limb. Participants will help basic research. There are no associated risks in participating.
Where is the study run from?
The study will be conducted in the Neurokinex centres (UK). The participants will be examined in the centre and dispensed the wearable device for domestic use. All further scheduled assessment will take place at the centre. All required equipment will be brought to the Neurokinex centre by Newcastle University (UK) for the duration of the study.
When is the study starting and how long is it expected to run for?
April 2019 to February 2022
Who is funding the study?
The study is funded by a Nathalie Rose Barr award from the International Spinal Research Trust (UK)
Who is the main contact?
Prof. Stuart Baker, stuart.baker@newcastle.ac.uk
Maria Germann, maria.germann2@newcastle.ac.uk
Contact information
Scientific
Henry Wellcome Building
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom
 ORCID ID |
0000-0001-8118-4048 |
|---|---|
| Phone | +44 (0) 191 208 6977 |
| stuart.baker@newcastle.ac.uk |
Scientific
Henry Wellcome Building
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom
| ORCID ID |
0000-0002-2747-9555 |
|---|---|
| Phone | +44 (0) 191 208 6977 |
| m.germann2@newcastle.ac.uk |
Public
Henry Wellcome Building
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom
| Phone | +44 (0) 191 208 6977 |
|---|---|
| m.germann2@newcastle.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre interventional randomized prospective study |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | Investigating electrophysiological changes in triceps after paired stimulation from a wearable device in chronic spinal cord injury survivors |
| Study objectives | In this study, we intend to test the impact of long term use of a wearable stimulating device on upper limb function in chronic spinal cord injury. We will compare the device, which will stimulate the triceps 10 ms before auditory click, with a group which will not receive any stimulation. We do not expect any plastic changes in reticulospinal tract or limb function in the second protocol; this serves as a control. |
| Ethics approval(s) | Approved 09/04/2019, Ethics committee of the faculty of medical sciences at Newcastle University (The Medical School, Newcastle University, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK; no telephone number provided; fmsethics@ncl.ac.uk), ref: 2020/5319/2020 |
| Health condition(s) or problem(s) studied | Chronic spinal cord injury |
| Intervention | Subjects fulfilling the selection criteria will be randomized (via computer generated code) to one of the two equal size parallel arms of the study. Group A: Will first receive the wearable device (electrical stimulation of triceps 10 ms before auditory click) and then spend 4 weeks without the device (control). Group B: Will first spend 4 weeks without the device (control) and then 4 weeks with the stimulation device. The study device is comprised of a plastic box about the size of a smart phone, containing an electrical stimulator and audio amplifier, powered by an internal battery which can be recharged via a standard microUSB port. The wearable device generates constant-current electrical stimulation to the target muscle through surface electrodes (220 V compliance, 150 μs pulse width). A knob on the device allows adjustment of the stimulus intensity, which is set to be just below the motor threshold (defined as a visible muscle twitch). Adequate care will be taken to prevent accidental increment of stimulus strength. Auditory stimuli are generated by delivering a 0.1 ms wide, 12 V square excitation pulse into a miniature earpiece; this produces a brief click with an intensity of 110 dB SPL. The earpiece is placed in the contralateral ear. An internal flash memory with plasticity stimulus protocol will be inserted under the cover. The back side of the device will be custom made according to participants’ preference of carrying the device during his/ her awake hours. They can either clip it on their belt/ keep it on a specialized arm pouch or just keep inside the pocket of their trousers. The correct length of the wire will be chosen and the backside of the device will be custom made (fitted with a loop/ clip) accordingly during dispensing. An inbuilt clock will record the on and off time of the device which can be subsequently retrieved from the internal flash memory to monitor compliance. The participants will be instructed to use the device for at least four hours per day during their awake hours, at any time except during shower or bathing. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Newcastle Wearable Device |
| Primary outcome measure(s) |
Measured at baseline, after 4 and 8 weeks: |
| Key secondary outcome measure(s) |
1. Compliance (how long subjects use the device each day) using the device clock data and participants’ filled-up diary. |
| Completion date | 02/02/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 22 |
| Key inclusion criteria | 1. Chronic (>1 year) cervical injury (C2-C7) 2. Male or female at least 18 years of age 3. Detectable EMG activity in triceps 4. Without upper limb fracture or subluxation/ dislocation of joints within last six months. 5. Be able to follow study instructions and perform study tasks. 6. Willing to provide written informed consent; if necessary through an independent witness should the subject be unable to write themselves due to their injury. |
| Key exclusion criteria | 1. Exhibit major medical problems or poor physical conditions that would interfere with participation, as reported by the participant. 2. Excessive pain in any joint that might limit examination. 3. Participants with contraindications for TMS as confirmed by ‘TMS Adult Safety Screen’ questionnaire (Keel et al. 2001). |
| Date of first enrolment | 30/07/2021 |
| Date of final enrolment | 31/12/2021 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
31 Mark Rd
Hemel Hempstead
HP2 7BW
United Kingdom
Fleming Way
Crawley
RH10 9NE
United Kingdom
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in repository |
| IPD sharing plan | Each subject will be identified by a code and the individual identity and other sensitive information of the subjects will be kept strictly confidential at all time. However, the investigator will maintain a separate Subject Enrolment Log with details of the subject’s identification and contact information in case they are needed, for example, in the event of an SAE. All study related documents, study device and other materials will be maintained in secure storage at the trial site, and afterwards in the investigator’s offices at the Movement Laboratory, Newcastle University. All trial related documents will be archived safely at the Movement Laboratory following completion of the study. Such archival will be done for a period of at least two years from the date of study completion. Data will be uploaded to https://data.ncl.ac.uk . Data generated by this project will be in the form of computer files holding surface EMG signal waveforms recorded in response to stimuli. These files will be recorded by the Spike2 software package. Data will be made available after we publish the papers arising from the study. Data will be stored on https://data.ncl.ac.uk for at least 10 years and available to be downloaded by anyone. Raw data is uploaded in anonymous form and participants be asked to give consent for this at the beginning of the study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 17/07/2023 | 18/08/2023 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/08/2023: Publication reference added.
04/02/2022: The overall end date was changed from 28/02/2022 to 02/02/2022.
23/12/2021: The total final enrolment was added.
02/09/2021: The trial participating centre "Movement Laboratory" was added.
05/07/2021: Trial's existence confirmed by Newcastle University Faculty of Medical Sciences Ethics Committee.
