Development of a hand exoskeleton for precise stretch and resistance measurement in hand spasticity assessment
| ISRCTN | ISRCTN84987845 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84987845 |
| IRAS number | 336874 |
| Secondary identifying numbers | IRAS 336874 |
- Submission date
- 17/12/2023
- Registration date
- 23/04/2024
- Last edited
- 19/03/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Many people who have had a stroke face a tough challenge with hand spasticity. This can make muscles overactive and probably lead to a clenched fist, making it hard to use the hand. If not treated correctly, this can get worse and lead to permanent tightness. This study aims to test a newly designed device developed by the study team, a hand exoskeleton, to see how well it can measure and distinguish different levels of resistance in the hand joints. By understanding this, the study hopes to improve how doctors and therapists assess hand spasticity and, ultimately, help in the treatment and recovery of stroke survivors.
Who can participate?
Adults aged 18 years old and over who are suffering from hand spasticity
What does the study involve?
The study is specifically looking for individuals who experience some stiffness in their hands but can still move their fingers to a certain degree. Both men and women can participate, and they do not need to be in perfect health, as long as their stroke and hand condition fit the inclusion criteria. Physiotherapists will use the exoskeleton to conduct the experiments on participants, which will gently move their main finger joints at different speeds. Each participant will experience several trials, and the sensor data will be recorded and collected during the experiments. There is no need for any medication or invasive procedures—it's all about measuring movement.
What are the possible benefits and risks of participating?
Participants will not directly benefit from taking part in the study, but they will contribute to a greater understanding of hand spasticity, which may benefit future stroke survivors. The risks are minimal. Some might feel a little discomfort when moving their fingers, but we will be careful to avoid any significant discomfort or pain.
Where is the study run from?
The study will be conducted at the Charles Bell Pavilion in Astley Ainslie Hospital, Edinburgh, under the supervision of the hospital's specialised staff member, Dr Alyson Nelson.
When is the study starting and how long is it expected to run for?
December 2023 to October 2025
Who is funding the study?
EPSRC Centre for Doctoral Training in Robotics and Autonomous Systems under the grant reference EP/S023208/1
Who is the main contact?
Hao Yu (a PhD candidate) and his academic supervisor, Dr. Mustafa Suphi Erden, are leading the study, they can be reached for further information at hy2020@hw.ac.uk.
Contact information
Public, Scientific
41/3 Stenhouse Avenue West
Edinburgh
EH11 3EY
United Kingdom
 ORCID ID |
0000-0003-3489-6522 |
|---|---|
| Phone | +44 (0)7556713984 |
| hy2020@hw.ac.uk |
Principal Investigator
Earl Mountbatten Building, Herit-Watt University
Edinburgh
EH14 4AS
United Kingdom
| ORCID ID |
0000-0001-6199-9151 |
|---|---|
| Phone | None provided |
| m.s.erden@hw.ac.uk |
Study information
| Study design | Single-centre experimental study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Device evaluation and diagnostic testing study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | 44765 PIS.pdf |
| Scientific title | Validation of a novel hand exoskeleton for discriminating hand spasticity levels in post-stroke patients based on stretch-induced resistance |
| Study acronym | HEXAS (Hand EXoskeleton for Assessing Spasticity) |
| Study objectives | This study is a device evaluation and diagnostic testing study. It aims to validate a new hand exoskeleton for assessing spasticity and advance the assessment of hand spasticity in post-stroke patients, addressing the unreliability of traditional manual assessment methods like the Modified Ashworth Scale (MAS). These conventional techniques, while widely used, lack consistent reliability and precise quantification, especially in differentiating neural and non-neural components of finger joint resistance. Our novel hand exoskeleton prototype shows promise in overcoming these limitations by providing objective, data-driven assessments based on stretch-induced resistance of finger joints. Although previous prototype testing on healthy individuals has demonstrated its movement and measurement functionality and safety, there is a critical need for experimental data from actual patients with hand spasticity. This study will analyse the sensor data collected with the exoskeleton prototype in the experiments to test two hypotheses: 1. The hand exoskeleton is capable of differentiating healthy individuals and those with hand spasticity. 2. The hand exoskeleton is capable of discriminating spastic hands with different MAS scores (0, 1, 1+, 2, and 3) |
| Ethics approval(s) |
Not yet submitted 15/12/2023, National Health Service Research Ethics Committees (Health Research Authority, 2 Redman Place, Stratford, London, E20 1JQ, United Kingdom) |
| Health condition(s) or problem(s) studied | Assessment of hand spasticity in adult patients 1 week to 6 months post-stroke, with a Modified Ashworth Scale (MAS) score of 0-3. |
| Intervention | Initially, participants will be assessed for spasticity using the Modified Ashworth Scale (MAS) by a physiotherapist. Before deploying the device, the researchers will measure the length of each finger segment and estimate the natural range of motion (ROM) for the main joints of their dominant hand suffering from spasticity. These measurements will then be input into the exoskeleton's control software. The exoskeleton will be utilised to extend and flex these joints at various speeds ranging from 30 to 300 degrees per second (in 30-degree-per-second increments, from slow to a speed that would cause discomfort, staying within their ROM). Five trials will be conducted at each speed, during which joint angles and resistance forces will be recorded for subsequent analysis. After using the exoskeleton, participants will be asked to complete the System Usability Scale about their experience with the device. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Hand exoskeleton |
| Primary outcome measure | 1. Hand spasticity measured using the Modified Ashworth Scale (MAS) by a physiotherapist at baseline 2. Features of the experimental data (e.g. mean resistance force) will be identified and used as the variables of hypothesis tests of the difference between healthy people and the spastic participants. 3. All experimental data will also undergo machine learning analysis to ascertain if any discernible patterns or characteristics can effectively discriminate between different levels of hand spasticity, as categorized by the MAS. |
| Secondary outcome measures | The usability of the device and user experience will be evaluated with questionnaires based on the System Usability Scale at [timepoint] |
| Overall study start date | 15/12/2023 |
| Completion date | 01/10/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Adults who have been medically diagnosed with hand spasticity 2. Participants' dominant hand is assessed as 1 to 3 MAS. 3. Participants should have the cognitive ability to understand the study and provide informed consent, as well as the ability to communicate any discomfort or issues during the study. 4. The capacity to comprehend and adhere to the study's requirements, especially important for interacting with the exoskeleton and providing feedback. |
| Key exclusion criteria | 1. Participants should not experience severe pain in the affected hand that could be aggravated by the use of the exoskeleton. 2. Ensuring there are no medical reasons, such as specific implants or severe deformities, that would contraindicate the use of the hand exoskeleton. |
| Date of first enrolment | 01/02/2024 |
| Date of final enrolment | 01/10/2025 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centres
Currie
Edinburgh
EH14 4AS
United Kingdom
Edinburgh
Lothian
EH9 2HL
United Kingdom
Sponsor information
Government
UK Research and Innovation
Polaris House
Swindon
SN2 1FL
England
United Kingdom
| Phone | +44 (0)1793 444000 |
|---|---|
| grants@epsrc.ukri.org | |
| Website | https://www.ukri.org/councils/epsrc/ |
"ROR" |
https://ror.org/0439y7842 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- UKRI Engineering and Physical Sciences Research Council, Engineering and Physical Sciences Research Council - UKRI, Engineering & Physical Sciences Research Council, EPSRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/10/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publications in high-impact peer-reviewed journals and conferences in the field of robotics and rehabilitiation. |
| IPD sharing plan | The datasets generated and analysed during the current study will be published as a supplement to the resulting publications. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 18/03/2024 | No | Yes |
Additional files
Editorial Notes
18/03/2024: Trial's existence confirmed by Edinburgh Centre for Robotics.
