Condition category
Nervous System Diseases
Date applied
03/06/2019
Date assigned
06/06/2019
Last edited
07/06/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Mrs Hwa Kee Ooi

ORCID ID

http://orcid.org/0000-0003-4085-8434

Contact details

Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
Kuala Lumpur
50300
Malaysia
+60165322535
ooihwakee@yahoo.co.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

NMRR-16-423-29688

Study information

Scientific title

The effectiveness of pressure garment in the management of spasticity and upper extremity function among stroke patients

Acronym

PGUE

Study hypothesis

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

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

Study design

Interventional open-label single centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

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

Phase

Not Applicable

Drug names

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 trial start date

10/12/2015

Overall trial end date

01/06/2017

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

All participants 46. 23 in each group.

Participant 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.

Recruitment start date

10/06/2016

Recruitment end date

01/06/2017

Locations

Countries of recruitment

Malaysia

Trial participating centre

Tengku Ampuan Rahimah Hospital
Jalan Langat
Klang
41200
Malaysia

Sponsor information

Organisation

Universiti Kebangsaan Malaysia

Sponsor details

Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
Kuala Lumpur
50300
Malaysia

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Plan to publish the study in Clinical Rehabilitation Journal this year.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to data protection regulations.

Intention to publish date

01/07/2019

Participant level data

Available on request

Basic results (scientific)

Forty-three (IG = 21; CG = 22) participants completed the interventions. Both intervention group and control group were comparable pre-intervention.
There were no significant between-group differences in MMAS and DASH post-intervention. Both groups only showed significant within-group improvements in MMAS fingers extension (IG: p = 0.002; CG: p = 0.01) and DASH (IG: p < 0.001; CG: p = 0.02).
Post intervention, only intervention group showed significant improvement in JTHFT for Subtest 5 and 6 within group differences.

Publication list

Publication citations

Additional files

Editorial Notes

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.