Effects of Accelerated Skill Acquisition Programme With Segmental Vibration on Upper Limb in Stroke.

NCT ID: NCT07128823

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-10
• Study Completion Date: 2025-12-30

Brief Summary

Stroke is a major health burden and the leading cause of serious long-term disability around the world. One of the most cumbersome deficits after a unilateral stroke is impairment in the contralateral upper limb. Segmental vibration is an intervention that incorporates sensory stimulation to improve motor cortical excitability. This study aims to investigate the influence of a 15-minute SMV application along with accelerated skill acquisition programme (ASAP) on spasticity, motor function, manual dexterity, and somatosensory function of the Upper Limb in Subacute stroke.

This study will be a randomized clinical trial conducted in the physiotherapy department of DHQ Hospital Gujranwala, Gondal Hospital, and Dayan Physiotherapy and Rehabilitation over 10 months. Using the Online Randomizer tool, 60 stroke patients will be recruited through a non-probability convenience sampling technique and randomly divided into two equal groups, Group A and Group B. Group A will receive ASAP with high-frequency segmental vibration(100Hz) on the extensor muscles while Group B, will receive accelerated skill acquisition programme (ASAP) with only. The Assessment tools are the Fugl-Meyer Assessment Scale (for upper limb function), Wolf Motor Functional Test(for motor function), Modified Ashworth Scale(for spasticity), Maximal Hand Grip Strength(for manual dexterity), Nottingham Sensory Assessment(for somatosensory function). Outcome measures will be assessed at baseline,4th week,8th week, and 12th week. Follow-up will be performed in the 16th week. Data analysis will be done by SPSS version 28.0. Two-way Mixed ANOVA, repeated measure ANOVA, and one-way ANOVA will be used in case of normal distribution of data. The Friedman, Kruskal Wallis, and Wilcoxon sign rank tests will be used for non-normal data.

Detailed Description

A stroke is a clinically defined syndrome of rapidly developing symptoms or signs of focal loss of cerebral function with no apparent cause other than that of vascular origin. Still, the loss of function can at times be global (applied to patients in a deep coma and those with subarachnoid hemorrhage. Stroke affects approximately 80.1 million people worldwide and causes 5.5 million deaths annually. The risk of stroke is highest between the ages of 55 and 65. Impaired functional movement in a paretic hand is a common post-stroke challenge. Upper extremity hemiparesis is one of the most common symptoms after stroke. Approximately 55%-75% of stroke survivors suffer from upper extremity moto dysfunction, 40% experience moderate to severe problems in the upper extremity. Which can have a considerable impact on activities of daily living and ultimately lead to a significant reduction in quality of life. The segmental vibrator with (ASAP) Task-Oriented training may have the potential to offer targeted, precise, and adaptable interventions, possibly optimizing the rehabilitation process by reinforcing the neural pathways associated with specific movements, promoting better improvement of motor tasks, their efficacy will aid in providing the rehabilitation strategies that may optimize the upper limb function in sub-acute stroke.

Conditions

Subacute Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A

(High-frequency segmental vibration and ASAP with with Routine Physical Therapy)

Group Type: EXPERIMENTAL

Group A (High-frequency segmental vibration and ASAP with Routine Physical Therapy)

Intervention Type: OTHER

A Segmental vibration device was used to provide vibratory stimulation with a frequency of 100 Hz and an amplitude of 1.0 mm. This stimulation was used because vibratory stimulation with a high frequency (80-120 Hz) and low amplitude can elicit strong activity in Ia afferents from the muscle spindles. 100 Hz frequency vibration was applied perpendicularly along the muscle fibers of the forearm extensor muscle (extensor carpi ulnaris (ECU), extensor carpi radialis (ECR), triceps).

The Accelerated Skill Acquisition Programme (ASAP), a structured, taskoriented motor training program for the upper extremities, is a best-practice synthesis implementing neuroscientific evidence regarding motor training approaches and schedules. The Accelerated Skill Acquisition Program (ASAP) for subacute stroke patients focuses on integrating motor training with motivational enhancement and impairment mitigation.

Group B

Accelerated skill acquisition programme with Routine Physical Therapy

Group Type: EXPERIMENTAL

Group B (Accelerated Skill Acquisition Programme with Routine Physical Therapy)

Intervention Type: OTHER

Exercises within the ASAP typically include:

Task-Specific Training: Patients engage in activities that mimic daily tasks, such as reaching, grasping, and manipulating objects, to improve their functional abilities Repetitive Practice: Patients perform repetitive movements to strengthen neural pathways and improve motor skills. This can involve tasks like buttoning a shirt, picking up small objects, or pouring water Bilateral Arm Training: This approach involves using both arms simultaneously to perform coordinated tasks, enhancing bimanual skills and improving upper extremity functions Motivational Strategies: The program incorporates motivational techniques to enhance patient engagement and adherence to the exercises, ensuring sustained practice and better outcomes.

Interventions

Group A (High-frequency segmental vibration and ASAP with Routine Physical Therapy)

A Segmental vibration device was used to provide vibratory stimulation with a frequency of 100 Hz and an amplitude of 1.0 mm. This stimulation was used because vibratory stimulation with a high frequency (80-120 Hz) and low amplitude can elicit strong activity in Ia afferents from the muscle spindles. 100 Hz frequency vibration was applied perpendicularly along the muscle fibers of the forearm extensor muscle (extensor carpi ulnaris (ECU), extensor carpi radialis (ECR), triceps).

The Accelerated Skill Acquisition Programme (ASAP), a structured, taskoriented motor training program for the upper extremities, is a best-practice synthesis implementing neuroscientific evidence regarding motor training approaches and schedules. The Accelerated Skill Acquisition Program (ASAP) for subacute stroke patients focuses on integrating motor training with motivational enhancement and impairment mitigation.

Intervention Type: OTHER

Group B (Accelerated Skill Acquisition Programme with Routine Physical Therapy)

Exercises within the ASAP typically include:

Task-Specific Training: Patients engage in activities that mimic daily tasks, such as reaching, grasping, and manipulating objects, to improve their functional abilities Repetitive Practice: Patients perform repetitive movements to strengthen neural pathways and improve motor skills. This can involve tasks like buttoning a shirt, picking up small objects, or pouring water Bilateral Arm Training: This approach involves using both arms simultaneously to perform coordinated tasks, enhancing bimanual skills and improving upper extremity functions Motivational Strategies: The program incorporates motivational techniques to enhance patient engagement and adherence to the exercises, ensuring sustained practice and better outcomes.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Unilateral stroke between 3 months and 6 months post-stroke.
• Fugl-Meyer assessment upper extremity (FMA-UE) motor scores between 19 and 58.
• Participants be able to follow the researcher's instructions and study procedures.
• Spasticity of spastic agonist muscles ranging from 0-2 on the modified Ashworth scale
• Montreal Cognitive Assessment (MoCA) score of 24 or higher, indicating sufficient cognitive function to participate in stroke rehabilitation.

Exclusion Criteria

Patients with acute or chronic neurologic or orthopedic impairments and those who experienced discomfort or had undergone surgery in the upper limbs within 6 months before the study onset. (30)

• Pain (FMA-UE pain score of 1 for at least 2 joints) in the affected UE.(32)
• All types of aphasia.(38)
• Visual problems that could not be corrected.(39)
• Individuals with unstable medical conditions that could interfere with rehabilitation progress or pose risks during therapy sessions are typically excluded(40)
• Patients with uncontrolled psychiatric disorders that could compromise their ability to participate in or benefit from rehabilitation are typically excluded(41)
• Metal implants e. g cardiac pacemaker

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aruba Saeed, PhD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

DHQ Hospital Gujranwala, Gondal Hospital, and Dayan Physiotherapy and Rehabilitation

Chak Two Hundred Fourteen, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Mubeen Arshad, MS-NMPT*

Role: CONTACT

Mubeenarshad1999@gmail.com

+923413193628

References

Adhikari SP , Gautam M . The Effectiveness of Accelerated Skill Acquisition Program for Upper Extremity Motor Training in Bilateral Stroke. Kathmandu Univ Med J (KUMJ). 2019 Oct.-Dec.;17(68):341-343.

Reference Type: BACKGROUND

PMID: 33311046 (View on PubMed)

Thant AA, Wanpen S, Nualnetr N, Puntumetakul R, Chatchawan U, Hla KM, Khin MT. Effects of task-oriented training on upper extremity functional performance in patients with sub-acute stroke: a randomized controlled trial. J Phys Ther Sci. 2019 Jan;31(1):82-87. doi: 10.1589/jpts.31.82. Epub 2019 Jan 29.

Reference Type: BACKGROUND

PMID: 30774211 (View on PubMed)

Moon JH, Cho HY, Hahm SC. Influence of Electrotherapy with Task-Oriented Training on Spasticity, Hand Function, Upper Limb Function, and Activities of Daily Living in Patients with Subacute Stroke: A Double-Blinded, Randomized, Controlled Trial. Healthcare (Basel). 2021 Aug 3;9(8):987. doi: 10.3390/healthcare9080987.

Reference Type: BACKGROUND

PMID: 34442124 (View on PubMed)

Kimura N, Sato M, Kobayashi Y, Naito E. Augmented activity of the forearm extensor muscles induced by vibratory stimulation of the palm of the hand in individuals with subacute post-stroke hemiplegia. Brain Inj. 2022 May 12;36(6):782-791. doi: 10.1080/02699052.2022.2048694. Epub 2022 Apr 17.

Reference Type: BACKGROUND

PMID: 35430945 (View on PubMed)

Choi W. The Effect of Task-Oriented Training on Upper-Limb Function, Visual Perception, and Activities of Daily Living in Acute Stroke Patients: A Pilot Study. Int J Environ Res Public Health. 2022 Mar 8;19(6):3186. doi: 10.3390/ijerph19063186.

Reference Type: BACKGROUND

PMID: 35328874 (View on PubMed)

Abit Kocaman A, Onal B, Sertel M, Karaca G. The effect of local vibration applied to the forearm extensor muscles on hand function and muscle activation in stroke patients: a randomized controlled study. Acta Neurol Belg. 2023 Oct;123(5):1957-1964. doi: 10.1007/s13760-023-02335-6. Epub 2023 Jul 23.

Reference Type: BACKGROUND

PMID: 37481756 (View on PubMed)

Tavernese E, Paoloni M, Mangone M, Mandic V, Sale P, Franceschini M, Santilli V. Segmental muscle vibration improves reaching movement in patients with chronic stroke. A randomized controlled trial. NeuroRehabilitation. 2013;32(3):591-9. doi: 10.3233/NRE-130881.

Reference Type: BACKGROUND

PMID: 23648613 (View on PubMed)

Annino G, Alashram AR, Alghwiri AA, Romagnoli C, Messina G, Tancredi V, Padua E, Mercuri NB. Effect of segmental muscle vibration on upper extremity functional ability poststroke: A randomized controlled trial. Medicine (Baltimore). 2019 Feb;98(7):e14444. doi: 10.1097/MD.0000000000014444.

Reference Type: BACKGROUND

PMID: 30762754 (View on PubMed)

Arya KN, Verma R, Garg RK, Sharma VP, Agarwal M, Aggarwal GG. Meaningful task-specific training (MTST) for stroke rehabilitation: a randomized controlled trial. Top Stroke Rehabil. 2012 May-Jun;19(3):193-211. doi: 10.1310/tsr1903-193.

Reference Type: BACKGROUND

PMID: 22668675 (View on PubMed)

Caliandro P, Celletti C, Padua L, Minciotti I, Russo G, Granata G, La Torre G, Granieri E, Camerota F. Focal muscle vibration in the treatment of upper limb spasticity: a pilot randomized controlled trial in patients with chronic stroke. Arch Phys Med Rehabil. 2012 Sep;93(9):1656-61. doi: 10.1016/j.apmr.2012.04.002. Epub 2012 Apr 13.

Reference Type: BACKGROUND

PMID: 22507444 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22402727 (View on PubMed)

Anwer S, Waris A, Gilani SO, Iqbal J, Shaikh N, Pujari AN, Niazi IK. Rehabilitation of Upper Limb Motor Impairment in Stroke: A Narrative Review on the Prevalence, Risk Factors, and Economic Statistics of Stroke and State of the Art Therapies. Healthcare (Basel). 2022 Jan 19;10(2):190. doi: 10.3390/healthcare10020190.

Reference Type: BACKGROUND

PMID: 35206805 (View on PubMed)

GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):439-458. doi: 10.1016/S1474-4422(19)30034-1. Epub 2019 Mar 11.

Reference Type: BACKGROUND

PMID: 30871944 (View on PubMed)

Other Identifiers

REC/0259 Mubeen Arshad

Identifier Type: -

Identifier Source: org_study_id