StrokeNCT05725941
Spiral Strapping for Improving Upper Limb Functions
A study testing TogRite stretch Strapping and Traditional upper limb functional exercise training in people with Stroke and Splints, run by Umm Al-Qura University at 1 site in Saudi Arabia.
Trial summary
Upper limb recovery after stroke is unacceptably poor with almost half of stroke survivors likely to regain some functional use. The rehabilitation process for upper extremity for individuals with stroke is of long duration and clinicians face the challenge of identifying a variety of assistive appliances that may be… Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Stroke, Splints, Physical Disability
- What is being tested?
- TogRite stretch Strapping and Traditional upper limb functional exercise training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 25 Jan 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The inclusion criteria were as follow:
- Participants were diagnosed as chronic stroke patients.
- Participants were selected to be in the spastic phase.
- The degree of spasticity in the affected upper limbs, was ranged between grades (1, 1+\&2) according to Modified Ashworth Scale.
- Participants were all between 50 and 60 years old, of both sexes.
- Participants were cognitively able to understand and follow instructions.
- Participants had the ability to extend their wrist joints at least 20° and fingers 10° from full flexion. This range allowed participants to engage easily in performing a designed functional program.
Who cannot join
- The exclusion criteria were as follow:
- Participants who were with any orthopedic condition or fixed deformity that interfere with the upper limb functions.
- Participants who were with spasticity of more than score 2 according to the Modified Ashworth Scale.
- Participants who had cognitive or perceptual problems.
- Participants with seizures, visual impairments, or auditory problems.
- Participants who had shoulder pain on a visual analogue scale of > 6/10.
- Participants who had Botulinum Toxin in the upper extremity musculature six months before baseline assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Spiral Strapping on Upper Limb Functions in Individuals with Stroke
Upper limb recovery after stroke is unacceptably poor with almost half of stroke survivors likely to regain some functional use. The rehabilitation process for upper extremity for individuals with stroke is of long duration and clinicians face the challenge of identifying a variety of assistive appliances that may be adapted and graded to facilitate this process. One of these appliances that is widely used in rehabilitation is splint and strapping. Therefore, this study aims to investigate the effectiveness of this modality in rehabilitation of the upper limb in stroke survivors.
Read the detailed description
Stroke often results in spasticity and associated motor impairments in the upper limb Spasticity in the upper limb commonly interferes with its motor activities, and results in impairments in the upper limb muscles. Persistent upper limb impairments can lead to limitations in activities of daily living, and quality of life. Assistive devices to facilitate the use of the hemiplegic upper extremity are considered to be the most important modalities in improving the functions of the upper limb. The splint is one of the most assistive tools in the rehabilitation of such individuals. The supportive and corrective functions provided by upper limb and hand splints have been shown to inhibit spasticity and promote the capabilities of the upper limb in individuals with stroke This study aims to evaluate the effectiveness of spiral strapping on inhibition of spasticity and improving upper limb functions in individuals with chronic stroke.
- Conditions
- Stroke, Splints, Physical Disability
- Being tested
- TogRite stretch Strapping, Traditional upper limb functional exercise training
- Keywords
- Stroke, Upper Limb Functions, Spiral Strapping
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TogRite stretch StrappingDevice
it is a machine washable and highly durable elastic strap that maintains its recoil strength for a long-lasting period. It is made of latex-free materials. The TogRite Strapping can be used to support the weakened parts of the body and adjust or modify the position and posture of different body parts.
Traditional upper limb functional exercise trainingOther
The traditional upper limb functional exercise training will focus on the enhancement of muscle strength, joint range of motion, arm \&hand activities, and daily living functions of the affected upper limbs.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Individuals who will participate in the control group will receive a traditional functional exercise training protocol (conventional physiotherapy program) for one hour. It will focus on the enhancement of muscle strength, joint range of motion, arm \&hand activities, and daily living functions of the affected upper limbs.
The treatment, for the control group, will be conducted over a period of 4 successive weeks, with 3 sessions per week. Receives: Other: Traditional upper limb functional exercise training |
| Experimental Group | Experimental | Participants in the experimental group will receive the conventional treatment program similar to that will be provided to the control group. The treatment, for the experimental group, will be conducted over a period of 4 successive weeks, with 3 sessions per week.
Moreover, they will ¬wear an upper limb spiral strapping system with a hand splint 8 hours daily/ 6 days per week. Receives: Device: TogRite stretch Strapping; Other: Traditional upper limb functional exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the score of The Action Research Arm Test (test that assess the change in upper extremity functions)
The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals with hemiplegia. It assesses a patient's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation. The ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement. The ARAT is scored on a four-level ordinal scale (0-3): 0 = cannot perform any part of the test, 1 = performs partially, 2 = take long time to complete the test, and 3 = performs the test normally. The total score on the ARAT ranges from 0 to 57, with the lowest score indicating that no movements can be performed, and the upper score indicating normal performance. Thus, the higher the score a patient get after completion of the treatment program compared to the baseline score, the better the improvement in upper extremity motor functions.
Measured: [Data was collected at baseline, and 4weeks after intervention commencement.] (i.e. Difference between The Action Research Arm Test Score at both baseline and completion of 4 weeks of intervention)
Change in the Modified Ashworth Scale (scale that assess the change in muscle tone)
Modified Ashworth Scale was used to evaluate the degree of spasticity in the involved upper limb in the elbow and wrist joints. MAS is a valid and a reliable scale to evaluate the degree of muscle tone for all participants pre and post treatment. It is scored on a 6 -graded ordinal scale.
Measured: [Data was collected at baseline, and 4weeks after intervention commencement.] (i.e. Difference between The Action Research Arm Test Score at both baseline and completion of 4 weeks of intervention)
Change in the upper limb' joints range of motion (in degree)
Digital Goniometer was used to evaluate the following joints range of motion (shoulder abduction\& external rotation, elbow extension and forearm supination). The Digital Goniometer has used a sensor to calculate the amount of joint range of motion in degrees to measure the true range of motion value.
Measured: [Data was collected at baseline, and 4 weeks after intervention commencement.] (i.e. Difference between The Action Research Arm Test Score at both baseline and completion of 4 weeks of intervention)
Secondary outcomes (1)
Change in the Hand Grip Strength of the involved upper extremity (Kg) (which indicate the change of the strength of the involved hand muscles in patients with stroke).
Hand Grip Dynamometer was used to assess the change in the strength of the hand muscles of the involved upper extremity. The higher the score of the hand grip after completion of the treatment program compared to the baseline score, the better the improvement of hand functional abilities.
Measured: [Data was collected at baseline, and 4 weeks after intervention commencement.] (i.e. Difference between The Action Research Arm Test Score at both baseline and completion of 4 weeks of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start25 Jan 2023
- Primary completion25 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Nourah Bint Abdulrahman University
- Responsible party
- Principal investigator, Ehab Mohamed Abd El Kafy, Umm Al-Qura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725941
- Sponsor's protocol ID
- RI-4-0588
- Status last verified
- Jan 2023
- First submitted
- 23 Jan 2023
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: \- The data available is Case-by-case basis at the discretion of the Primary Sponsor
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Spiral Strapping on Upper Limb Functions in Individuals with Stroke
- ClinicalTrials.gov ID
- NCT05725941
- Acronym / sponsor ID
- RI-4-0588
- Conditions
- Stroke, Splints, Physical Disability
- Keywords
- Stroke, Upper Limb Functions, Spiral Strapping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Collaborators
- Princess Nourah Bint Abdulrahman University
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 13 Feb 2023 (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.
Upper limb recovery after stroke is unacceptably poor with almost half of stroke survivors likely to regain some functional use. The rehabilitation process for upper extremity for individuals with stroke is of long duration and clinicians face the challenge of identifying a variety of assistive appliances that may be adapted and graded to facilitate this process. One of these appliances that is widely used in rehabilitation is splint and strapping. Therefore, this study aims to investigate the effectiveness of this modality in rehabilitation of the upper limb in stroke survivors.
Detailed description
Stroke often results in spasticity and associated motor impairments in the upper limb Spasticity in the upper limb commonly interferes with its motor activities, and results in impairments in the upper limb muscles. Persistent upper limb impairments can lead to limitations in activities of daily living, and quality of life. Assistive devices to facilitate the use of the hemiplegic upper extremity are considered to be the most important modalities in improving the functions of the upper limb. The splint is one of the most assistive tools in the rehabilitation of such individuals. The supportive and corrective functions provided by upper limb and hand splints have been shown to inhibit spasticity and promote the capabilities of the upper limb in individuals with stroke This study aims to evaluate the effectiveness of spiral strapping on inhibition of spasticity and improving upper limb functions in individuals with chronic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Traditional upper limb functional exercise trainingIndividuals who will participate in the control group will receive a traditional functional exercise training protocol (conventional physiotherapy program) for one hour. It will focus on the enhancement of muscle strength, joint range of motion, arm \&hand activities, and daily living functions of the affected upper limbs. The treatment, for the control group, will be conducted over a period of 4 successive weeks, with 3 sessions per week. |
| Experimental Group | Experimental | Device: TogRite stretch Strapping, Other: Traditional upper limb functional exercise trainingParticipants in the experimental group will receive the conventional treatment program similar to that will be provided to the control group. The treatment, for the experimental group, will be conducted over a period of 4 successive weeks, with 3 sessions per week. Moreover, they will ¬wear an upper limb spiral strapping system with a hand splint 8 hours daily/ 6 days per week. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants were diagnosed as chronic stroke patients.
- Participants were selected to be in the spastic phase.
- The degree of spasticity in the affected upper limbs, was ranged between grades (1, 1+\&2) according to Modified Ashworth Scale.
- Participants were all between 50 and 60 years old, of both sexes.
- Participants were cognitively able to understand and follow instructions.
Key exclusion criteria (7 listed)
- Participants who were with any orthopedic condition or fixed deformity that interfere with the upper limb functions.
- Participants who were with spasticity of more than score 2 according to the Modified Ashworth Scale.
- Participants who had cognitive or perceptual problems.
- Participants with seizures, visual impairments, or auditory problems.
- Participants who had shoulder pain on a visual analogue scale of > 6/10.
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 |
|---|---|---|
| TogRite stretch Strappingit is a machine washable and highly durable elastic strap that maintains its recoil strength for a long-lasting period. It is made of latex-free materials. The TogRite Strapping can be used to support the weakened parts of the body and adjust or modify the position and posture of different body parts. | Device | Experimental Group |
| Traditional upper limb functional exercise trainingThe traditional upper limb functional exercise training will focus on the enhancement of muscle strength, joint range of motion, arm \&hand activities, and daily living functions of the affected upper limbs. | Other | Control Group, Experimental Group |
Primary outcome
Change in the score of The Action Research Arm Test (test that assess the change in upper extremity functions)
Time frame: [Data was collected at baseline, and 4weeks after intervention commencement.] (i.e. Difference between The Action Research Arm Test Score at both baseline and completion of 4 weeks of intervention)
The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals with hemiplegia. It assesses a patient's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation. The ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement. The ARAT is scored on a four-level ordinal scale (0-3): 0 = cannot perform any part of the test, 1 = performs partially, 2 = take long time to complete the test, and 3 = performs the test normally. The total score on the ARAT ranges from 0 to 57, with the lowest score indicating that no movements can be performed, and the upper score indicating normal performance. Thus, the higher the score a patient get after completion of the treatment program compared to the baseline score, the better the improvement in upper extremity motor functions.
Change in the Modified Ashworth Scale (scale that assess the change in muscle tone)
Time frame: [Data was collected at baseline, and 4weeks after intervention commencement.] (i.e. Difference between The Action Research Arm Test Score at both baseline and completion of 4 weeks of intervention)
Modified Ashworth Scale was used to evaluate the degree of spasticity in the involved upper limb in the elbow and wrist joints. MAS is a valid and a reliable scale to evaluate the degree of muscle tone for all participants pre and post treatment. It is scored on a 6 -graded ordinal scale.
Change in the upper limb' joints range of motion (in degree)
Time frame: [Data was collected at baseline, and 4 weeks after intervention commencement.] (i.e. Difference between The Action Research Arm Test Score at both baseline and completion of 4 weeks of intervention)
Digital Goniometer was used to evaluate the following joints range of motion (shoulder abduction\& external rotation, elbow extension and forearm supination). The Digital Goniometer has used a sensor to calculate the amount of joint range of motion in degrees to measure the true range of motion value.
1 secondary outcome
Change in the Hand Grip Strength of the involved upper extremity (Kg) (which indicate the change of the strength of the involved hand muscles in patients with stroke).
Time frame: [Data was collected at baseline, and 4 weeks after intervention commencement.] (i.e. Difference between The Action Research Arm Test Score at both baseline and completion of 4 weeks of intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: Yes. - The data available is Case-by-case basis at the discretion of the Primary Sponsor
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TogRite stretch Strapping and Traditional upper limb functional exercise training in people with Stroke and Splints, run by Umm Al-Qura University at 1 site in Saudi Arabia.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the score of The Action Research Arm Test (test that assess the change in upper extremity functions) (time frame: [Data was collected at baseline, and 4weeks after intervention commencement.] (i.e. Difference between The Action Research Arm Test Score at both baseline and completion of 4 weeks of intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2025.