Anti-Spastic Splint With Focal Muscle Vibration for Stroke Hand Spasticity

Spasticity as Sequela of Stroke Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06358976
• Other study ID #: Spasticity splint and FMV
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: Arab American University (Palestine)
• Contact: Amer Jaroshy, MSc
• Phone: 0597103320
• Email: amer.jaroshy[@]aaup.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: December 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity as Sequela of Stroke
• Stroke

Intervention

Other:
• Vibration plus anti-spastic hand splint
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 splint
the use of anti-spastic hand splint alone.
• Vibration
The use of hand vibrator alone

Locations

Country	Name	City	State
Palestinian Territory, occupied	Arab American University	Jenin

Sponsors (1)

Lead Sponsor	Collaborator
Arab American University (Palestine)

Country where clinical trial is conducted

Palestinian Territory, occupied, 

References & Publications (32)

Alashram 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. — View Citation

Alghadir 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. — View Citation

Amatya 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;(2):CD009974. doi: 10.1002/14651858.CD009974.pub2. — View Citation

Andringa 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. — View Citation

Arain 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. — View Citation

Beebe 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. — View Citation

Davis 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. — View Citation

de 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. — View Citation

Eldridge 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. — View Citation

Elfil M, Negida A. Sampling methods in Clinical Research; an Educational Review. Emerg (Tehran). 2017;5(1):e52. Epub 2017 Jan 14. — View Citation

Fattorini 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. — View Citation

Feigin 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. Erratum In: Lancet. 2014 Jan 18;383(9913):218. — View Citation

Francisco 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. — View Citation

Gregson 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. — View Citation

Hernandez ED, Galeano CP, Barbosa NE, Forero SM, Nordin A, Sunnerhagen KS, Alt Murphy M. Intra- and inter-rater reliability of Fugl-Meyer Assessment of Upper Extremity in stroke. J Rehabil Med. 2019 Oct 4;51(9):652-659. doi: 10.2340/16501977-2590. — View Citation

Katan M, Luft A. Global Burden of Stroke. Semin Neurol. 2018 Apr;38(2):208-211. doi: 10.1055/s-0038-1649503. Epub 2018 May 23. — View Citation

Kerr L, Jewell VD, Jensen L. Stretching and Splinting Interventions for Poststroke Spasticity, Hand Function, and Functional Tasks: A Systematic Review. Am J Occup Ther. 2020 Sep/Oct;74(5):7405205050p1-7405205050p15. doi: 10.5014/ajot.2020.029454. — View Citation

Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x. — View Citation

Lannin NA, Herbert RD. Is hand splinting effective for adults following stroke? A systematic review and methodologic critique of published research. Clin Rehabil. 2003 Dec;17(8):807-16. doi: 10.1191/0269215503cr682oa. — View Citation

Nam KE, Lim SH, Kim JS, Hong BY, Jung HY, Lee JK, Yoo SD, Pyun SB, Lee KM, Lee KJ, Kim H, Han EY, Lee KW. When does spasticity in the upper limb develop after a first stroke? A nationwide observational study on 861 stroke patients. J Clin Neurosci. 2019 Aug;66:144-148. doi: 10.1016/j.jocn.2019.04.034. Epub 2019 May 11. — View Citation

Noma T, Matsumoto S, Shimodozono M, Etoh S, Kawahira K. Anti-spastic effects of the direct application of vibratory stimuli to the spastic muscles of hemiplegic limbs in post-stroke patients: a proof-of-principle study. J Rehabil Med. 2012 Apr;44(4):325-30. doi: 10.2340/16501977-0946. — View Citation

Pathak A, Gyanpuri V, Dev P, Dhiman NR. The Bobath Concept (NDT) as rehabilitation in stroke patients: A systematic review. J Family Med Prim Care. 2021 Nov;10(11):3983-3990. doi: 10.4103/jfmpc.jfmpc_528_21. Epub 2021 Nov 29. — View Citation

Phadke CP, Balasubramanian CK, Ismail F, Boulias C. Revisiting physiologic and psychologic triggers that increase spasticity. Am J Phys Med Rehabil. 2013 Apr;92(4):357-69. doi: 10.1097/phm.0b013e31827d68a4. — View Citation

Poenaru D, Cinteza D, Petrusca I, Cioc L, Dumitrascu D. Local Application of Vibration in Motor Rehabilitation - Scientific and Practical Considerations. Maedica (Bucur). 2016 Sep;11(3):227-231. — View Citation

Shiner CT, Vratsistas-Curto A, Bramah V, Faux SG, Watanabe Y. Prevalence of upper-limb spasticity and its impact on care among nursing home residents with prior stroke. Disabil Rehabil. 2020 Jul;42(15):2170-2177. doi: 10.1080/09638288.2018.1555620. Epub 2019 Mar 31. — View Citation

Sommerfeld DK, Eek EU, Svensson AK, Holmqvist LW, von Arbin MH. Spasticity after stroke: its occurrence and association with motor impairments and activity limitations. Stroke. 2004 Jan;35(1):134-9. doi: 10.1161/01.STR.0000105386.05173.5E. Epub 2003 Dec 18. — View Citation

Suputtitada A, Chatromyen S, Chen CPC, Simpson DM. Best Practice Guidelines for the Management of Patients with Post-Stroke Spasticity: A Modified Scoping Review. Toxins (Basel). 2024 Feb 10;16(2):98. doi: 10.3390/toxins16020098. — View Citation

Suresh K, Thomas SV, Suresh G. Design, data analysis and sampling techniques for clinical research. Ann Indian Acad Neurol. 2011 Oct;14(4):287-90. doi: 10.4103/0972-2327.91951. — View Citation

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. — View Citation

Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1. Erratum In: BMC Med Res Methodol. 2023 Mar 11;23(1):59. — View Citation

Welmer AK, Widen Holmqvist L, Sommerfeld DK. Location and severity of spasticity in the first 1-2 weeks and at 3 and 18 months after stroke. Eur J Neurol. 2010 May;17(5):720-5. doi: 10.1111/j.1468-1331.2009.02915.x. Epub 2009 Dec 29. — View Citation

World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available. — View Citation

* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At day one, and the end of the intervention (after 4 weeks).
Primary	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.	At day one, and the end of the intervention (after 4 weeks).
Primary	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.	At day one, and the end of the intervention (after 4 weeks).
Primary	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.	At day one, and the end of the intervention (after 4 weeks).