Effects of pressure garment in managing arm function among stroke patients
| ISRCTN | ISRCTN10425224 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10425224 |
| Secondary identifying numbers | NMRR-16-423-29688 |
- Submission date
- 03/06/2019
- Registration date
- 06/06/2019
- Last edited
- 21/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
After a stroke (a serious life-threatening medical condition that occurs when the blood supply to part of the brain is cut off), damage to the brain can block messages between muscles and the brain causing arm and leg muscles to cramp or spasm (spasticity). This post-stroke condition makes daily activities such as bathing, eating and dressing more difficult. Spasticity can cause long periods of strong contractions in major muscle groups, causing painful muscle spasms. The aim of this study is to test the effect of a new tight-fitting pressure garment worn on the affected arm/hand on spasticity over a six-week occupational therapy program.
Who can participate?
Aged 21 years old and above, between one month and 12 months post-stroke.
What does the study involve?
All participants will take part in a conventional occupational therapy program for two hours every week. Half of the participants will wear a custom fitted pressure garment on the affected arm for six hours a day for six weeks.
What are the possible benefits and risks of participating?
There may or may not be any benefits of participating in the study. Information obtained from this study will help improve the treatment or management of other participants with the same disease or condition.
Potential risks of participating in this study:
a) Upper extremity becomes discoloured (white/ blue) or skin allergy.
b) Pain and loss of sensation in the affected hand.
c) The pressure garment is too tight and painful.
The participants are allowed to remove pressure garment if these symptoms occur and inform the therapist immediately.
Where is the study run from?
Tengku Ampuan Rahimah Hospital, Malaysia
When is the study starting and how long is it expected to run for?
June 2016 to June 2017
Who is funding the study?
Investigator funded
Who is the main contact?
Mrs Hwa Kee Ooi,
ooihwakee@yahoo.co.uk
Contact information
Public
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
Kuala Lumpur
50300
Malaysia
 ORCID ID |
0000-0003-4085-8434 |
|---|---|
| Phone | +60165322535 |
| ooihwakee@yahoo.co.uk |
Study information
| Study design | Interventional open-label single centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN10425224_PIS_06Jun2019.pdf |
| Scientific title | The effectiveness of pressure garment in the management of spasticity and upper extremity function among stroke patients |
| Study acronym | PGUE |
| Study objectives | The participants in the intervention group were gained greater improvement in all three outcomes as compared to those in the control group after 6 weeks of pressure garment (PG) intervention. |
| Ethics approval(s) | Approved 06/06/2016, Medical Research and Ethics Committee, Ministry of Health Malaysia (Blok A, Kompleks Institut Kesihatan Negara [NIH], No.1 Jalan Setia Murni U13/52, Seksyen U13 Bandar Setia Alam, 40170, Shah Alam, Malaysia; 03-22874032; nmrr@moh.gov.my) ref: NMRR-16-423-29688 |
| Health condition(s) or problem(s) studied | Stroke recovery |
| Intervention | Forty-six envelopes with number 1 to 46 were randomly chosen by one of the therapists who was blinded to the study protocol, i.e. therapist who was not treating patients with neurological conditions and also not involved in the numbering and envelope preparations. Participants who received odd numbers were allocated in the intervention group and those received even numbers were allocated in the control group. Both the intervention group and the control group participated in a conventional occupational therapy program for 2 hours every week. Twenty-three participants in the intervention group were given custom fitted pressure garment (PG) at the affected upper extremity (UE). PG was custom fabricated using Lycra material by the researcher of this study. The pattern of the affected hand and the circumference of the mid-forearm of each participant in the intervention group was measured to ensure the fabricated PG fits exactly well on the forearm and hand. Participants in the intervention group were required to wear the PG for 6 hours a day for 6 weeks continuously. The necessary adjustment was made on the PG to maintain its tight fit. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | All participants were assessed pre-intervention and 6 weeks post-intervention: 1. Spasticity as measured by the Modified Modified Ashworth Scale (MMAS) 2. Hand function as measured by the Jebsen Taylor Hand Function Test for the actual performance 3. Disabilities of Arm, Shoulder and Hand (DASH) Outcome Measure for the self-report measurement |
| Secondary outcome measures | none |
| Overall study start date | 10/12/2015 |
| Completion date | 01/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | All participants 46. 23 in each group. |
| Total final enrolment | 46 |
| Key inclusion criteria | 1. Patient aged 21 years old and above 2. Between one month and 12 months post-stroke (ischemic or hemorrhagic adult stroke) 3. Absence of severe cognitive problems with Mini Mental State Examination (MMSE) score of at least 24 4. Modified Ashworth Scale of 1, 2 or 3 when wrist and hand perform flexion and extension movements |
| Key exclusion criteria | 1. Behavior disturbances or serious chronic diseases that can interfere with the ability to give informed consent or cooperation in the study. 2. History of UE injuries, e.g. fracture, tendon injuries in the affected side. |
| Date of first enrolment | 10/06/2016 |
| Date of final enrolment | 01/06/2017 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Klang
41200
Malaysia
Sponsor information
University/education
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
Kuala Lumpur
50300
Malaysia
"ROR" |
https://ror.org/01590nj79 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Plan to publish the study in Clinical Rehabilitation Journal this year. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to data protection regulations. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 06/06/2019 | 07/06/2019 | No | Yes | |
| Results article | results | 01/04/2020 | 21/05/2020 | Yes | No |
Additional files
- ISRCTN10425224_PIS_06Jun2019.pdf
- uploaded 07/06/2019
Editorial Notes
21/05/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
20/01/2020: The intention to publish date has been changed from 01/07/2019 to 01/06/2020.
27/08/2019: Internal review.
07/06/2019: The participant information sheet has been uploaded as an additional file.
06/06/2019: Trial’s existence confirmed by Medical Research and Ethics Committee, Ministry of Health Malaysia.
