Cerebral Vascular Accident (CVA)/StrokeNCT06587308
Effects of Different Pressure Garments on Upper Extremity Sensorimotor Functions and Quality of Life After Stroke
A study testing Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment, Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment and Single-Layered No Circumferential Reduction (S-0) Pressure Garment in people with Cerebral Vascular Accident (CVA)/Stroke, run by National University of Malaysia at 3 sites in China.
Trial summary
The study aims to compare the effects of dorsal-double-layered 10% circumferential reduction (DD-10), single-layered 10% circumferential reduction (S-10), and single-layered no circumferential reduction (S-0) pressure garments on sensorimotor functions, including motor control, dexterity, muscle tone, pain… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebral Vascular Accident (CVA)/Stroke
- What is being tested?
- Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment, Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment and Single-Layered No Circumferential Reduction (S-0) Pressure Garment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 3 sitesChina
- Study dates
- 8 Oct 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 80 years of age
- Within 1-12 months of ischemic or hemorrhagic stroke
- First onset resulting in hemiparesis of a limb with Burnnstrom stage of 3, 4 or 5
- Modified Ashworth Scale with scores of less than or equal 2 for elbow, wrist, and hand muscle tone in the affected upper extremity
- Able to understand instruction
Who cannot join
- Serious cardiovascular or respiratory diseases
- Skin lesions, infections or other skin problems
- Serious circulatory problems such as deep vein thrombosis
- Allergies or significant discomfort to pressure garment materials
- Upper extremity fractures or severe joint problems
- Severe cognitive impairment with Saint Louis University Mental Status (SLUMs) scores equal to or less than 27 (above high school level of education)/25 (below high school level of education)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
The Affiliated Hospital of Shandong Second Medical University
Weifang, Shandong, 261000
Kuicheng Li, MOT, 8613926144818, kuichengli@163.com
- Recruiting
Weifang Hospital of Traditional Chinese Medicine
Weifang, Shandong, 261000
Kuicheng Li, MOT, 8613926144818, kuichengli@163.com
- Recruiting
Weifang Municipal Peoples Hospital
Weifang, Shandong, 261000
Kuicheng Li, MOT, 8613926144818, kuichengli@163.com
About this study
Official title: Effects of Pressure Garments of Varying Designs on Upper Extremity Sensorimotor Functions and Quality of Life After Stroke: A Multicenter, Double-Blind, Prospective Randomized Controlled Trial
The study aims to compare the effects of dorsal-double-layered 10% circumferential reduction (DD-10), single-layered 10% circumferential reduction (S-10), and single-layered no circumferential reduction (S-0) pressure garments on sensorimotor functions, including motor control, dexterity, muscle tone, pain, self-perceived upper extremity function, and quality of life among stroke patients during the 8 weeks of application (Time 1: Baseline, Time 2: Week 4, Time 3: Week 8).
- Conditions
- Cerebral Vascular Accident (CVA)/Stroke
- Being tested
- Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment, Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment, Single-Layered No Circumferential Reduction (S-0) Pressure Garment
- Keywords
- Pressure Garment, Quality of Life, Stroke Rehabilitation, Occupational Therapy, Motor Activity, Sensory Feedback, Upper Extremity Paresis
- Medical subject headings
- Stroke, Motor Activity, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure GarmentOther
During Phase IA, i.e., the first four weeks between Time 1 (Baseline) and Time 2 (Week 4), when participants are hospitalized in the rehabilitation department of the hospital. participants will need to wear the DD-10 pressure garment for 3 hours in the morning, 3 hours in the afternoon, and 8 hours at night daily. Additionally, all participants will need to attend an occupational therapy session for 30 minutes, 5 days a week. During Phase IB, i.e., the second four weeks between Time 2 (Week 4), and Time 3 (Week 8), when participants were being discharged from the hospital, they need to continually wearing the pressure garment according to same wearing schedule; however, the participants will not need to attend the occupational therapy session.
Single-Layered 10% Circumferential Reduction (S-10) Pressure GarmentOther
During Phase IA, i.e., the first four weeks between Time 1 (Baseline) and Time 2 (Week 4), when participants are hospitalized in the rehabilitation department of the hospital. participants will need to wear the S-10 pressure garment for 3 hours in the morning, 3 hours in the afternoon, and 8 hours at night daily. Additionally, all participants will need to attend an occupational therapy session for 30 minutes, 5 days a week. During Phase IB, i.e., the second four weeks between Time 2 (Week 4), and Time 3 (Week 8), when participants were being discharged from the hospital, they need to continually wearing the pressure garment according to same wearing schedule; however, the participants will not need to attend the occupational therapy session.
Single-Layered No Circumferential Reduction (S-0) Pressure GarmentOther
During Phase IA, i.e., the first four weeks between Time 1 (Baseline) and Time 2 (Week 4), when participants are hospitalized in the rehabilitation department of the hospital. participants will need to wear the S-0 pressure garment for 3 hours in the morning, 3 hours in the afternoon, and 8 hours at night daily. Additionally, all participants will need to attend an occupational therapy session for 30 minutes, 5 days a week. During Phase IB, i.e., the second four weeks between Time 2 (Week 4), and Time 3 (Week 8), when participants were being discharged from the hospital, they need to continually wearing the pressure garment according to same wearing schedule; however, the participants will not need to attend the occupational therapy session.
| Study group | Role | What they receive |
|---|---|---|
| Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment | Experimental | A custom-fabricated finger-to-above-elbow (long glove) pressure garment with 10% of stress. The design is similar to S-10 except it has an extra layer of fabric on the dorsal aspect that gives stronger compression Receives: Other: Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment |
| Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment | Active comparator | A custom-fabricated single-layered finger-to-above-elbow (long glove) pressure garment with 10% of stress. Receives: Other: Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment |
| Single-Layered No Circumferential Reduction (S-0) Pressure Garment | Placebo comparator | A custom-fabricated single-layered finger-to-above-elbow (long glove) pressure garment with 0% of stress Receives: Other: Single-Layered No Circumferential Reduction (S-0) Pressure Garment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment (FMA)
A classic tool used to assess the rehabilitation process of stroke patients from the aspects of sensorimotor function and level of life activities. It has two main domains, i.e., upper extremity and lower extremity. The 33-item upper extremity domain that will be used in this study includes the range of motion of the shoulder, elbow, wrist, and fingers as well as elements such as grip strength and hand coordination. Scored between 0 and 66, higher scores indicating greater function.
Measured: Baseline, Week 4. Week 8
Secondary outcomes (5)
Modified Ashworth Scale (MAS)
A method used to assess muscle tone or muscle spasticity. It uses a scale of 0 to 4, where 0 indicates no spasticity and 4 indicates severe spasticity.
Measured: Baseline, Week 4. Week 8
Visual Analogue Scale (VAS)
A 10-cm pain scale with one end of the scale represents no pain and the other end represents unbearable pain. Subjective perception of pain is obtained by drawing a vertical line between these two endpoints.
Measured: Baseline, Week 4. Week 8
Box and Block Test (BBT)
A quantitative tool used to assess upper extremity sensorimotor function, including hand coordination, dexterity, speed of movement, and fine hand movements. Assessment is done by transferring a set of cubes from one side of a box separated into two equal-sized compartments (by a divider) to the other side within one minute.
Measured: Baseline, Week 4. Week 8
Disabilities of Arm, Shoulder and Hand (DASH) Outcome Measure
A widely used tool for assessing upper extremity function. Its disability/symptom module has 30 items that covers a wide range of functional daily activities. Scored between 0 and 100, higher scores indicating more severe disability.
Measured: Baseline, Week 4. Week 8
36-Item Short Form Health Survey (SF-36)
A 36-item survey questionnaire designed to provide insight into health status and quality of life of an individual, allowing comprehensive assessment of physical, psychological, and social functioning. Each dimension is converted into a score of 100 points by assigning weights to the entries according to the degree to which they affect the quality of life. The level of the score directly reflects the health status, with higher scores indicating better functional status and quality of life in this area.
Measured: Baseline, Week 4. Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start8 Oct 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Vascular Accident (CVA)/StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Shandong Second Medical University, Weifang Municipal People's Hospital, Weifang Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- SIaw Chui Chai, PhD, Principal investigator, Occupational Therapy Programme, Centre for Rehabilitation and Special Needs Studies (iCaRehab)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587308
- Sponsor's protocol ID
- JEP-2024-582
- Status last verified
- Nov 2024
- First submitted
- 4 Sep 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu Z, Chai SC, Chu SY, Li K. Effects of pressure garments of varying designs on upper extremity sensorimotor functions and quality of life after stroke: Study protocol for a multicenter, double-blind, prospective randomized controlled trial. PLoS One. 2025 Jun 23;20(6):e0326680. doi: 10.1371/journal.pone.0326680. eCollection 2025.
PubMed 40549786
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pressure Garments of Varying Designs on Upper Extremity Sensorimotor Functions and Quality of Life After Stroke: A Multicenter, Double-Blind, Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06587308
- Acronym / sponsor ID
- JEP-2024-582
- Conditions
- Cerebral Vascular Accident (CVA)/Stroke
- Keywords
- Pressure Garment, Quality of Life, Stroke Rehabilitation, Occupational Therapy, Motor Activity, Sensory Feedback, Upper Extremity Paresis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Shandong Second Medical University, Weifang Municipal People's Hospital, Weifang Hospital of Traditional Chinese Medicine
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to compare the effects of dorsal-double-layered 10% circumferential reduction (DD-10), single-layered 10% circumferential reduction (S-10), and single-layered no circumferential reduction (S-0) pressure garments on sensorimotor functions, including motor control, dexterity, muscle tone, pain, self-perceived upper extremity function, and quality of life among stroke patients during the 8 weeks of application (Time 1: Baseline, Time 2: Week 4, Time 3: Week 8).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment | Experimental | Other: Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure GarmentA custom-fabricated finger-to-above-elbow (long glove) pressure garment with 10% of stress. The design is similar to S-10 except it has an extra layer of fabric on the dorsal aspect that gives stronger compression |
| Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment | Active comparator | Other: Single-Layered 10% Circumferential Reduction (S-10) Pressure GarmentA custom-fabricated single-layered finger-to-above-elbow (long glove) pressure garment with 10% of stress. |
| Single-Layered No Circumferential Reduction (S-0) Pressure Garment | Placebo comparator | Other: Single-Layered No Circumferential Reduction (S-0) Pressure GarmentA custom-fabricated single-layered finger-to-above-elbow (long glove) pressure garment with 0% of stress |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Between 18 and 80 years of age
- Within 1-12 months of ischemic or hemorrhagic stroke
- First onset resulting in hemiparesis of a limb with Burnnstrom stage of 3, 4 or 5
- Modified Ashworth Scale with scores of less than or equal 2 for elbow, wrist, and hand muscle tone in the affected upper extremity
- Able to understand instruction
Key exclusion criteria (6 listed)
- Serious cardiovascular or respiratory diseases
- Skin lesions, infections or other skin problems
- Serious circulatory problems such as deep vein thrombosis
- Allergies or significant discomfort to pressure garment materials
- Upper extremity fractures or severe joint problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure GarmentDuring Phase IA, i.e., the first four weeks between Time 1 (Baseline) and Time 2 (Week 4), when participants are hospitalized in the rehabilitation department of the hospital. participants will need to wear the DD-10 pressure garment for 3 hours in the morning, 3 hours in the afternoon, and 8 hours at night daily. Additionally, all participants will need to attend an occupational therapy session for 30 minutes, 5 days a week. During Phase IB, i.e., the second four weeks between Time 2 (Week 4), and Time 3 (Week 8), when participants were being discharged from the hospital, they need to continually wearing the pressure garment according to same wearing schedule; however, the participants will not need to attend the occupational therapy session. | Other | Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment |
| Single-Layered 10% Circumferential Reduction (S-10) Pressure GarmentDuring Phase IA, i.e., the first four weeks between Time 1 (Baseline) and Time 2 (Week 4), when participants are hospitalized in the rehabilitation department of the hospital. participants will need to wear the S-10 pressure garment for 3 hours in the morning, 3 hours in the afternoon, and 8 hours at night daily. Additionally, all participants will need to attend an occupational therapy session for 30 minutes, 5 days a week. During Phase IB, i.e., the second four weeks between Time 2 (Week 4), and Time 3 (Week 8), when participants were being discharged from the hospital, they need to continually wearing the pressure garment according to same wearing schedule; however, the participants will not need to attend the occupational therapy session. | Other | Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment |
| Single-Layered No Circumferential Reduction (S-0) Pressure GarmentDuring Phase IA, i.e., the first four weeks between Time 1 (Baseline) and Time 2 (Week 4), when participants are hospitalized in the rehabilitation department of the hospital. participants will need to wear the S-0 pressure garment for 3 hours in the morning, 3 hours in the afternoon, and 8 hours at night daily. Additionally, all participants will need to attend an occupational therapy session for 30 minutes, 5 days a week. During Phase IB, i.e., the second four weeks between Time 2 (Week 4), and Time 3 (Week 8), when participants were being discharged from the hospital, they need to continually wearing the pressure garment according to same wearing schedule; however, the participants will not need to attend the occupational therapy session. | Other | Single-Layered No Circumferential Reduction (S-0) Pressure Garment |
Primary outcome
Fugl-Meyer Assessment (FMA)
Time frame: Baseline, Week 4. Week 8
A classic tool used to assess the rehabilitation process of stroke patients from the aspects of sensorimotor function and level of life activities. It has two main domains, i.e., upper extremity and lower extremity. The 33-item upper extremity domain that will be used in this study includes the range of motion of the shoulder, elbow, wrist, and fingers as well as elements such as grip strength and hand coordination. Scored between 0 and 66, higher scores indicating greater function.
5 secondary outcomes
Modified Ashworth Scale (MAS)
Time frame: Baseline, Week 4. Week 8
Visual Analogue Scale (VAS)
Time frame: Baseline, Week 4. Week 8
Box and Block Test (BBT)
Time frame: Baseline, Week 4. Week 8
Disabilities of Arm, Shoulder and Hand (DASH) Outcome Measure
Time frame: Baseline, Week 4. Week 8
36-Item Short Form Health Survey (SF-36)
Time frame: Baseline, Week 4. Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Derived from this study: PubMed 40549786Xu Z, Chai SC, Chu SY, Li K. Effects of pressure garments of varying designs on upper extremity sensorimotor functions and quality of life after stroke: Study protocol for a multicenter, double-blind, prospective randomized controlled trial. PLoS One. 2025 Jun 23;20(6):e0326680. doi: 10.1371/journal.pone.0326680. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
SIaw Chui Chai, PhD principal investigator
Occupational Therapy Programme, Centre for Rehabilitation and Special Needs Studies (iCaRehab)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment, Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment and Single-Layered No Circumferential Reduction (S-0) Pressure Garment in people with Cerebral Vascular Accident (CVA)/Stroke, run by National University of Malaysia at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenkun Xu, MSc (0129838798, P126687@siswa.ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment (FMA) (time frame: Baseline, Week 4. Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06587308, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.