Spasticity as Sequela of StrokeNCT06358976
Anti-Spastic Splint With Focal Muscle Vibration for Stroke Hand Spasticity
A study testing Vibration plus anti-spastic hand splint, Anti-spastic hand splint and Vibration in people with Spasticity as Sequela of Stroke, run by Arab American University (Palestine) at 1 site in Palestinian Territories.
Trial summary
Title: The Effect of Vibrating Splint on Hand Function After Stroke Summary: This study aims to investigate the effectiveness of a vibrating splint in improving hand function and reducing spasticity among individuals who have experienced a stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity as Sequela of Stroke
- What is being tested?
- Vibration plus anti-spastic hand splint, Anti-spastic hand splint and Vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 1 Aug 2024to 30 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals affected by chronic (more than one year) spastic ischemic or hemorrhagic stroke
- Aged above 18 years old
- Medically stable (has no cardiovascular event in the last 12 months)
- A score of 1-4 on modified Ashworth scale.
Who cannot join
- Cardiovascular event in the past 12 months
- Received anti-spastic injections drugs into the affected hand in the last 6 months
- A score of less than 21 on Rowland Universal Dementia Assessment Scale (RUDAS)
- Upper limb and trunk musculoskeletal injuries
- A score of 0 on modified Ashworth scale.
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Arab American University
Jenin, 240
Hisham Arab Alkabeya, PhD, 0595637776, hisham.arabkkabeya@aaup.edu
About this study
Official title: The Effectiveness of Anti-spastic Splint With Added Focal Muscle Vibration (FMV) in Decreasing Hand Spasticity and Improving Hand Functionality Among Individuals With Chronic Stroke: a Pilot Randomized Control Trial
Title: The Effect of Vibrating Splint on Hand Function After Stroke
Summary:
Read more
This study aims to investigate the effectiveness of a vibrating splint in improving hand function and reducing spasticity among individuals who have experienced a stroke. Stroke is a major global health issue, often resulting in long-term disability and impairments in the upper limbs. Spasticity, a common complication of stroke, causes stiffness and involuntary muscle contractions, leading to difficulties in performing daily activities.
Current treatment options for spasticity include medications and physical therapy techniques. However, these approaches may have limitations in terms of effectiveness and duration of benefits. Therefore, non-pharmacological interventions are being explored to enhance rehabilitation outcomes.
The hypothesis of this study is that the use of a vibrating splint, which applies mechanical vibrations to the hand muscles, will decrease spasticity and improve hand functionality in individuals with chronic stroke. The vibrations from the splint stimulate the sensory receptors in the skin and muscles, leading to muscle relaxation and improved motor control.
The study will be conducted as a pilot randomized controlled trial, involving participants who meet specific eligibility criteria. The participants will be divided into three arms, with each arm receiving a different intervention. Outcome measures, including assessments of spasticity, range of motion, pain levels, and functional abilities, will be collected before and after the intervention period.
The findings from this study will contribute to the understanding of non-pharmacological approaches in managing spasticity and improving hand function after stroke. If the vibrating splint proves to be effective, it could offer a safe and accessible option for stroke survivors to enhance their recovery and regain independence in daily activities.
This research is essential as it addresses the need for more effective interventions for spasticity management and hand rehabilitation after stroke. By providing valuable insights into the potential benefits of the vibrating splint, this study has the potential to improve the quality of life for individuals who have experienced a stroke and empower them to regain control over their hand movements.
Read the detailed description
This pilot randomized controlled trial (RCT) aims to assess the clinical effectiveness and efficacy of adding focal muscle vibration (FMV) to anti-spastic splint therapy for individuals with spasticity following a stroke. The study involves multiple centers in the Jenin area of Palestine, utilizing outpatient rehabilitation centers to recruit participants who have chronic spasticity post-stroke.
Study Objectives and Questions:
Determine whether adding FMV to anti-spastic splint therapy provides additional benefit for individuals with spasticity after a stroke.
Compare the outcomes of anti-spastic splint therapy, FMV therapy, and a combination of both interventions in individuals with post-stroke spasticity.
Explore participant perceptions regarding the effectiveness, acceptability, and adherence to the interventions.
Study Design and Procedures:
The study is a pilot, multi-center RCT with a single evaluator (evaluator-blind) approach to avoid bias.
Forty-eight participants will be randomly assigned to one of three groups: Arm 1 (anti-spastic splint and FMV), Arm 2 (FMV only), or Arm 3 (anti-spastic splint only).
Interventions will be delivered by trained rehabilitation specialists, including occupational and physical therapists.
Standardized intervention protocols will guide the delivery of FMV and anti-spastic splint therapy for a period of four weeks.
Participant Recruitment:
Participants with chronic post-stroke spasticity are recruited from multiple rehabilitation centers and screened based on specific inclusion and exclusion criteria.
Convenience sampling is used to enroll participants from available populations in the participating centers.
Data Collection and Management:
Baseline and post-treatment evaluations include measurements of spasticity, hand functionality, range of motion, and pain level.
Qualitative interviews will explore participants' experiences with the interventions and their perceptions of the treatments' effectiveness.
Data will be securely stored and anonymized to protect participants' privacy.
Statistical Analysis Plan:
Linear Mixed-Effects Models (LMEM) will be used to assess treatment effects, adjusting for correlation over time within participants.
The safety analysis will involve documenting and summarizing adverse events (AEs) across treatment groups.
The study aims to provide preliminary data on treatment effects and inform the design of future larger RCTs.
- Conditions
- Spasticity as Sequela of Stroke
- Being tested
- Vibration plus anti-spastic hand splint, Anti-spastic hand splint, Vibration
- Keywords
- Stroke, Spasticity, Vibration, Splint, Upper limb
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibration plus anti-spastic hand splintOther
vibration stimulation will be applied to the spastic hand antagonistic muscles using a volar anti-spastic hand splint and the Myovolt Arm vibrator.
Anti-spastic hand splintOther
the use of anti-spastic hand splint alone.
VibrationOther
The use of hand vibrator alone
| Study group | Role | What they receive |
|---|---|---|
| Vibration plus anti-spastic hand splint Arm | Experimental | In this clinical trial, vibration stimulation will be applied to the spastic hand antagonistic muscles using a specific device consisting of a volar anti-spastic hand splint and the arm vibrator. The volar anti-spastic hand splint will be custom-made for each participant at the prosthetic and orthotic clinic, following a standardized protocol. The arm vibrator, designed to fit the arm, will deliver the required vibration parameters. The intervention protocol involves a 30-minute vibration session administered three times weekly for four weeks, accompanied by daily utilization of the custom-made splint for 30 minutes each day. Receives: Other: Vibration plus anti-spastic hand splint |
| Anti-spastic hand splint Arm | Active comparator | In the anti-spastic hand splint arm , participants will be provided with an anti-spastic splint without vibration. Both vibration plus anti-spastic hand splint arm and anti-spastic hand splint arm will adhere to the same splint standard regime and recommendations, which outlines the specific positioning for the splint. Receives: Other: Anti-spastic hand splint |
| Vibration Arm | Active comparator | In vibration arm , participants will be provided with arm vibrator held in place by appropriate padded harness. A Standardized study protocol will be used each time with no splint. Receives: Other: Vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale (MAS)
Spasticity level will be evaluated using the MAS scale. The MAS measures muscle resistance during passive stretching. The test will be applied for spastic joints of affected upper extremities. The score will be recorded as (0, 1, +1, 2, 3, 4), (0= normal tone, 4 = affected part rigid in flexion or extension). The reliability of the modified Ashworth scale is very good (kappa = .84 for interrater and .83 for intra-rater comparisons). Measurement repetition will be performed by the same assessor to avoid affecting reliability.
The test will be conducted in the assessment quiet room, with no distractions. The participants will be supine in a treatment bed, and therapist will assess the affected upper limb spasticity once and record the result in the assessment form. The assessor will be a qualified trained occupational therapist who has worked in a clinical role treating stroke patients with hand spasticity and familiar with MAS.
Measured: At day one, and the end of the intervention (after 4 weeks).
Fugl-Meyer Assessment of Upper Extremity (FMA-UE)
The FMA-UE looks at reflex activity, volitional movement within synergies, volitional movement mixing synergies, and volitional movement with little or no synergy. The outcome scale's 33 items are divided into four subscales: shoulder and elbow, wrist, hand, and coordination. On a three-point ordinal scale, each of these items is assessed. 2 points are granted if a movement is completely completed, 1 point is awarded if the movement is half completed, and 0 points are awarded if the movement cannot be completed.
Measured: At day one, and the end of the intervention (after 4 weeks).
Range of Motion Assessment
The assessment of Range of Motion (ROM) for the affected upper limb in stroke patients will employ the use of a goniometer to precisely measure joint mobility across multiple planes of movement. This comprehensive evaluation entails examining the patient's ability to actively or passively articulate their affected elbow, wrist, and hand joints. The measurement of each movement will be made through the goniometer-based approach.
Measured: At day one, and the end of the intervention (after 4 weeks).
Numeric pain rating scale (NRS)
Numeric pain scale (NRS) is an essential tool for the assessment of pain intensity. It is widely used by healthcare providers. It consists of a horizontal line where the left end is labeled "no pain" or "0," indicating the absence of pain, while the right end is labeled as "worst pain imaginable" or "10". The participants are required to mark on the line the point that shows the pain level they are experiencing. The distance from the origin of the line, which is the left end, to the participant's symbol mark is the one that is used to present a numerical value. a representation which shows pain intensity, where the higher the value the more pain there is. The NRS is taken into account as a valid and reliable scale and is usually employed in to analyze pain intensity in clinical practice and to conduct research.
Measured: At day one, and the end of the intervention (after 4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Aug 2024 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Spasticity as Sequela of 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The interventional study model for this clinical study is a pilot randomized controlled trial. Participants will be randomly assigned to one of three arms: Group A (vibrating splint intervention), Group B (standard splint intervention), or Group C (control group receiving no splint intervention). This model allows for the comparison of different interventions and the evaluation of their effectiveness in improving hand function and reducing spasticity after stroke. Randomization helps ensure that each group is comparable in terms of baseline characteristics, minimizing bias and increasing the validity of the study results.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arab American University (Palestine)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amer Jaroshy, Arab American University (Palestine)
- Investigators
- Hisham Arab Alkabeya, PhD, Study chair, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358976
- Sponsor's protocol ID
- Spasticity splint and FMV
- Status last verified
- Apr 2024
- First submitted
- 6 Apr 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tedla JS, Gular K, Reddy RS, de Sa Ferreira A, Rodrigues EC, Kakaraparthi VN, Gyer G, Sangadala DR, Qasheesh M, Kovela RK, Nambi G. Effectiveness of Constraint-Induced Movement Therapy (CIMT) on Balance and Functional Mobility in the Stroke Population: A Systematic Review and Meta-Analysis. Healthcare (Basel). 2022 Mar 8;10(3):495. doi: 10.3390/healthcare10030495.
PubMed 35326973Alashram AR, Padua E, Romagnoli C, Annino G. Effectiveness of focal muscle vibration on hemiplegic upper extremity spasticity in individuals with stroke: A systematic review. NeuroRehabilitation. 2019 Dec 18;45(4):471-481. doi: 10.3233/NRE-192863.
PubMed 31868686Alghadir AH, Anwer S, Iqbal ZA. The psychometric properties of an Arabic numeric pain rating scale for measuring osteoarthritis knee pain. Disabil Rehabil. 2016 Dec;38(24):2392-7. doi: 10.3109/09638288.2015.1129441. Epub 2016 Jan 6.
PubMed 26733318Amatya B, Khan F, La Mantia L, Demetrios M, Wade DT. Non pharmacological interventions for spasticity in multiple sclerosis. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD009974. doi: 10.1002/14651858.CD009974.pub2.
PubMed 23450612Andringa A, van de Port I, Meijer JW. Long-term use of a static hand-wrist orthosis in chronic stroke patients: a pilot study. Stroke Res Treat. 2013;2013:546093. doi: 10.1155/2013/546093. Epub 2013 Feb 27.
PubMed 23533961Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010 Jul 16;10:67. doi: 10.1186/1471-2288-10-67.
PubMed 20637084Beebe JA, Lang CE. Active range of motion predicts upper extremity function 3 months after stroke. Stroke. 2009 May;40(5):1772-9. doi: 10.1161/STROKEAHA.108.536763. Epub 2009 Mar 5.
PubMed 19265051Davis EC, Barnes MP. Botulinum toxin and spasticity. J Neurol Neurosurg Psychiatry. 2000 Aug;69(2):143-7. doi: 10.1136/jnnp.69.2.143. No abstract available.
PubMed 10896682de Jong LD, Dijkstra PU, Stewart RE, Postema K. Repeated measurements of arm joint passive range of motion after stroke: interobserver reliability and sources of variation. Phys Ther. 2012 Aug;92(8):1027-35. doi: 10.2522/ptj.20110280. Epub 2012 May 10.
PubMed 22577062Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS One. 2016 Mar 15;11(3):e0150205. doi: 10.1371/journal.pone.0150205. eCollection 2016.
PubMed 26978655Elfil M, Negida A. Sampling methods in Clinical Research; an Educational Review. Emerg (Tehran). 2017;5(1):e52. Epub 2017 Jan 14.
PubMed 28286859Fattorini L, Ferraresi A, Rodio A, Azzena GB, Filippi GM. Motor performance changes induced by muscle vibration. Eur J Appl Physiol. 2006 Sep;98(1):79-87. doi: 10.1007/s00421-006-0250-5. Epub 2006 Aug 9.
PubMed 16896736Feigin VL, Forouzanfar MH, Krishnamurthi R, Mensah GA, Connor M, Bennett DA, Moran AE, Sacco RL, Anderson L, Truelsen T, O'Donnell M, Venketasubramanian N, Barker-Collo S, Lawes CM, Wang W, Shinohara Y, Witt E, Ezzati M, Naghavi M, Murray C; Global Burden of Diseases, Injuries, and Risk Factors Study 2010 (GBD 2010) and the GBD Stroke Experts Group. Global and regional burden of stroke during 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2014 Jan 18;383(9913):245-54. doi: 10.1016/s0140-6736(13)61953-4.
PubMed 24449944Francisco GE, McGuire JR. Poststroke spasticity management. Stroke. 2012 Nov;43(11):3132-6. doi: 10.1161/STROKEAHA.111.639831. Epub 2012 Sep 13. No abstract available.
PubMed 22984012Gregson JM, Leathley M, Moore AP, Sharma AK, Smith TL, Watkins CL. Reliability of the Tone Assessment Scale and the modified Ashworth scale as clinical tools for assessing poststroke spasticity. Arch Phys Med Rehabil. 1999 Sep;80(9):1013-6. doi: 10.1016/s0003-9993(99)90053-9.
PubMed 10489001
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Anti-spastic Splint With Added Focal Muscle Vibration (FMV) in Decreasing Hand Spasticity and Improving Hand Functionality Among Individuals With Chronic Stroke: a Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06358976
- Acronym / sponsor ID
- Spasticity splint and FMV
- Conditions
- Spasticity as Sequela of Stroke
- Keywords
- Stroke, Spasticity, Vibration, Splint, Upper limb
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Arab American University (Palestine)University, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 11 Apr 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.
Title: The Effect of Vibrating Splint on Hand Function After Stroke
Summary:
This study aims to investigate the effectiveness of a vibrating splint in improving hand function and reducing spasticity among individuals who have experienced a stroke. Stroke is a major global health issue, often resulting in long-term disability and impairments in the upper limbs. Spasticity, a common complication of stroke, causes stiffness and involuntary muscle contractions, leading to difficulties in performing daily activities.
Current treatment options for spasticity include medications and physical therapy techniques. However, these approaches may have limitations in terms of effectiveness and duration of benefits. Therefore, non-pharmacological interventions are being explored to enhance rehabilitation outcomes.
The hypothesis of this study is that the use of a vibrating splint, which applies mechanical vibrations to the hand muscles, will decrease spasticity and improve hand functionality in individuals with chronic stroke. The vibrations from the splint stimulate the sensory receptors in the skin and muscles, leading to muscle relaxation and improved motor control.
The study will be conducted as a pilot randomized controlled trial, involving participants who meet specific eligibility criteria. The participants will be divided into three arms, with each arm receiving a different intervention. Outcome measures, including assessments of spasticity, range of motion, pain levels, and functional abilities, will be collected before and after the intervention period.
The findings from this study will contribute to the understanding of non-pharmacological approaches in managing spasticity and improving hand function after stroke. If the vibrating splint proves to be effective, it could offer a safe and accessible option for stroke survivors to enhance their recovery and regain independence in daily activities.
This research is essential as it addresses the need for more effective interventions for spasticity management and hand rehabilitation after stroke. By providing valuable insights into the potential benefits of the vibrating splint, this study has the potential to improve the quality of life for individuals who have experienced a stroke and empower them to regain control over their hand movements.
Detailed description
This pilot randomized controlled trial (RCT) aims to assess the clinical effectiveness and efficacy of adding focal muscle vibration (FMV) to anti-spastic splint therapy for individuals with spasticity following a stroke. The study involves multiple centers in the Jenin area of Palestine, utilizing outpatient rehabilitation centers to recruit participants who have chronic spasticity post-stroke.
Study Objectives and Questions:
Determine whether adding FMV to anti-spastic splint therapy provides additional benefit for individuals with spasticity after a stroke.
Compare the outcomes of anti-spastic splint therapy, FMV therapy, and a combination of both interventions in individuals with post-stroke spasticity.
Explore participant perceptions regarding the effectiveness, acceptability, and adherence to the interventions.
Study Design and Procedures:
The study is a pilot, multi-center RCT with a single evaluator (evaluator-blind) approach to avoid bias.
Forty-eight participants will be randomly assigned to one of three groups: Arm 1 (anti-spastic splint and FMV), Arm 2 (FMV only), or Arm 3 (anti-spastic splint only).
Interventions will be delivered by trained rehabilitation specialists, including occupational and physical therapists.
Standardized intervention protocols will guide the delivery of FMV and anti-spastic splint therapy for a period of four weeks.
Participant Recruitment:
Participants with chronic post-stroke spasticity are recruited from multiple rehabilitation centers and screened based on specific inclusion and exclusion criteria.
Convenience sampling is used to enroll participants from available populations in the participating centers.
Data Collection and Management:
Baseline and post-treatment evaluations include measurements of spasticity, hand functionality, range of motion, and pain level.
Qualitative interviews will explore participants' experiences with the interventions and their perceptions of the treatments' effectiveness.
Data will be securely stored and anonymized to protect participants' privacy.
Statistical Analysis Plan:
Linear Mixed-Effects Models (LMEM) will be used to assess treatment effects, adjusting for correlation over time within participants.
The safety analysis will involve documenting and summarizing adverse events (AEs) across treatment groups.
The study aims to provide preliminary data on treatment effects and inform the design of future larger RCTs.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- The interventional study model for this clinical study is a pilot randomized controlled trial. Participants will be randomly assigned to one of three arms: Group A (vibrating splint intervention), Group B (standard splint intervention), or Group C (control group receiving no splint intervention). This model allows for the comparison of different interventions and the evaluation of their effectiveness in improving hand function and reducing spasticity after stroke. Randomization helps ensure that each group is comparable in terms of baseline characteristics, minimizing bias and increasing the validity of the study results.
| Arm | Type | Receives |
|---|---|---|
| Vibration plus anti-spastic hand splint Arm | Experimental | Other: Vibration plus anti-spastic hand splintIn this clinical trial, vibration stimulation will be applied to the spastic hand antagonistic muscles using a specific device consisting of a volar anti-spastic hand splint and the arm vibrator. The volar anti-spastic hand splint will be custom-made for each participant at the prosthetic and orthotic clinic, following a standardized protocol. The arm vibrator, designed to fit the arm, will deliver the required vibration parameters. The intervention protocol involves a 30-minute vibration session administered three times weekly for four weeks, accompanied by daily utilization of the custom-made splint for 30 minutes each day. |
| Anti-spastic hand splint Arm | Active comparator | Other: Anti-spastic hand splintIn the anti-spastic hand splint arm , participants will be provided with an anti-spastic splint without vibration. Both vibration plus anti-spastic hand splint arm and anti-spastic hand splint arm will adhere to the same splint standard regime and recommendations, which outlines the specific positioning for the splint. |
| Vibration Arm | Active comparator | Other: VibrationIn vibration arm , participants will be provided with arm vibrator held in place by appropriate padded harness. A Standardized study protocol will be used each time with no splint. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals affected by chronic (more than one year) spastic ischemic or hemorrhagic stroke
- Aged above 18 years old
- Medically stable (has no cardiovascular event in the last 12 months)
- A score of 1-4 on modified Ashworth scale.
Key exclusion criteria (5 listed)
- Cardiovascular event in the past 12 months
- Received anti-spastic injections drugs into the affected hand in the last 6 months
- A score of less than 21 on Rowland Universal Dementia Assessment Scale (RUDAS)
- Upper limb and trunk musculoskeletal injuries
- A score of 0 on modified Ashworth scale.
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 |
|---|---|---|
| Vibration plus anti-spastic hand splintvibration stimulation will be applied to the spastic hand antagonistic muscles using a volar anti-spastic hand splint and the Myovolt Arm vibrator. | Other | Vibration plus anti-spastic hand splint Arm |
| Anti-spastic hand splintthe use of anti-spastic hand splint alone. | Other | Anti-spastic hand splint Arm |
| VibrationThe use of hand vibrator alone | Other | Vibration Arm |
Primary outcome
Modified Ashworth Scale (MAS)
Time frame: At day one, and the end of the intervention (after 4 weeks).
Spasticity level will be evaluated using the MAS scale. The MAS measures muscle resistance during passive stretching. The test will be applied for spastic joints of affected upper extremities. The score will be recorded as (0, 1, +1, 2, 3, 4), (0= normal tone, 4 = affected part rigid in flexion or extension). The reliability of the modified Ashworth scale is very good (kappa = .84 for interrater and .83 for intra-rater comparisons). Measurement repetition will be performed by the same assessor to avoid affecting reliability. The test will be conducted in the assessment quiet room, with no distractions. The participants will be supine in a treatment bed, and therapist will assess the affected upper limb spasticity once and record the result in the assessment form. The assessor will be a qualified trained occupational therapist who has worked in a clinical role treating stroke patients with hand spasticity and familiar with MAS.
Fugl-Meyer Assessment of Upper Extremity (FMA-UE)
Time frame: At day one, and the end of the intervention (after 4 weeks).
The FMA-UE looks at reflex activity, volitional movement within synergies, volitional movement mixing synergies, and volitional movement with little or no synergy. The outcome scale's 33 items are divided into four subscales: shoulder and elbow, wrist, hand, and coordination. On a three-point ordinal scale, each of these items is assessed. 2 points are granted if a movement is completely completed, 1 point is awarded if the movement is half completed, and 0 points are awarded if the movement cannot be completed.
Range of Motion Assessment
Time frame: At day one, and the end of the intervention (after 4 weeks).
The assessment of Range of Motion (ROM) for the affected upper limb in stroke patients will employ the use of a goniometer to precisely measure joint mobility across multiple planes of movement. This comprehensive evaluation entails examining the patient's ability to actively or passively articulate their affected elbow, wrist, and hand joints. The measurement of each movement will be made through the goniometer-based approach.
Numeric pain rating scale (NRS)
Time frame: At day one, and the end of the intervention (after 4 weeks).
Numeric pain scale (NRS) is an essential tool for the assessment of pain intensity. It is widely used by healthcare providers. It consists of a horizontal line where the left end is labeled "no pain" or "0," indicating the absence of pain, while the right end is labeled as "worst pain imaginable" or "10". The participants are required to mark on the line the point that shows the pain level they are experiencing. The distance from the origin of the line, which is the left end, to the participant's symbol mark is the one that is used to present a numerical value. a representation which shows pain intensity, where the higher the value the more pain there is. The NRS is taken into account as a valid and reliable scale and is usually employed in to analyze pain intensity in clinical practice and to conduct research.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Background: PubMed 35326973Tedla JS, Gular K, Reddy RS, de Sa Ferreira A, Rodrigues EC, Kakaraparthi VN, Gyer G, Sangadala DR, Qasheesh M, Kovela RK, Nambi G. Effectiveness of Constraint-Induced Movement Therapy (CIMT) on Balance and Functional Mobility in the Stroke Population: A Systematic Review and Meta-Analysis. Healthcare (Basel). 2022 Mar 8;10(3):495. doi: 10.3390/healthcare10030495.
- Background: PubMed 31868686Alashram AR, Padua E, Romagnoli C, Annino G. Effectiveness of focal muscle vibration on hemiplegic upper extremity spasticity in individuals with stroke: A systematic review. NeuroRehabilitation. 2019 Dec 18;45(4):471-481. doi: 10.3233/NRE-192863.
- Background: PubMed 26733318Alghadir AH, Anwer S, Iqbal ZA. The psychometric properties of an Arabic numeric pain rating scale for measuring osteoarthritis knee pain. Disabil Rehabil. 2016 Dec;38(24):2392-7. doi: 10.3109/09638288.2015.1129441. Epub 2016 Jan 6.
- Background: PubMed 23450612Amatya B, Khan F, La Mantia L, Demetrios M, Wade DT. Non pharmacological interventions for spasticity in multiple sclerosis. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD009974. doi: 10.1002/14651858.CD009974.pub2.
- Background: PubMed 23533961Andringa A, van de Port I, Meijer JW. Long-term use of a static hand-wrist orthosis in chronic stroke patients: a pilot study. Stroke Res Treat. 2013;2013:546093. doi: 10.1155/2013/546093. Epub 2013 Feb 27.
- Background: PubMed 20637084Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010 Jul 16;10:67. doi: 10.1186/1471-2288-10-67.
- Background: PubMed 19265051Beebe JA, Lang CE. Active range of motion predicts upper extremity function 3 months after stroke. Stroke. 2009 May;40(5):1772-9. doi: 10.1161/STROKEAHA.108.536763. Epub 2009 Mar 5.
- Background: PubMed 10896682Davis EC, Barnes MP. Botulinum toxin and spasticity. J Neurol Neurosurg Psychiatry. 2000 Aug;69(2):143-7. doi: 10.1136/jnnp.69.2.143. No abstract available.
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- 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. This study is not recruiting at the moment.
Hisham Arab Alkabeya, PhD study chair
Assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibration plus anti-spastic hand splint, Anti-spastic hand splint and Vibration in people with Spasticity as Sequela of Stroke, run by Arab American University (Palestine) at 1 site in Palestinian Territories.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 Apr 2024. 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 Palestinian Territories. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amer Jaroshy, MSc (0597103320, amer.jaroshy@aaup.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (MAS) (time frame: At day one, and the end of the intervention (after 4 weeks).). The study lists 4 primary outcomes in all. 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 NCT06358976, which also lists 32 linked publications.
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 15 Apr 2024.