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Completed

NCT Number: NCT07128823

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

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.

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Key information

Conditions

Subacute Stroke

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Guiranwala, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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

Treatment and study plan

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

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)

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.

Primary outcomes

  1. Fugl-Meyer Assessment (FMA)

    Time frame: Assessment at baseline, after 4th,8th,12th and 16th weeks

    The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess the functioning, balance, sensation, and joint functioning in patients with stroke hemiplegia (0-126 points). Higher scores indicate better motor recovery, with subscores for specific domains like upper extremity (0-66).

Secondary outcomes

  1. Wolf Motor Functional Test (WMFT)

    Time frame: Assessment at baseline, after 4th,8th,12th and 16th week

    The Wolf Motor Functional Test (WMFT) measures upper extremity (UE) motor abilities by scoring 15 tasks on performance time and functional ability, with scores ranging from 0 (unable) to 5 (normal). Lower times and higher functional scores indicate better motor recovery.

  2. Modified Ashworth scale (MAS)

    Time frame: Assessment at baseline, after 4th ,8th ,12th and at 16th week.

    The Modified Ashworth Scale (MAS) measures spasticity in stroke patients by assessing muscle resistance to passive movement, scored from 0 to 4. A score of 0 indicates no increase in muscle tone, while 4 denotes a rigid limb. It is widely used in stroke rehabilitation to evaluate spasticity in upper or lower limbs. Higher scores correlate with greater spasticity.

  3. Maximal Hand Grip Strength (MHGS)

    Time frame: Assessment at baseline, after 4th ,8th ,12th and at 16th week.

    Maximal Hand Grip Strength (MHGS) is a key measure of upper limb function in stroke patients, typically assessed using a dynamometer. In subacute stroke, MHGS scores reflect muscle weakness, with values often ranging from 0-30 kg (compared to 40-50 kg in healthy adults), depending on severity. Lower scores indicate greater impairment, correlating with reduced functional ability in tasks like grasping.

  4. Nottingham Sensory Assessment (NSA)

    Time frame: Assessment at baseline, after 4th,8th,12th and 16th week.

    The Nottingham Sensory Assessment (NSA) is a standardized tool to evaluate sensory impairments in stroke patients, focusing on tactile sensation, proprioception, and stereognosis in the upper and lower limbs. It includes 20 items scored on a 3-point scale (0 = absent, 1 = impaired, 2 = normal), with separate testing for affected and unaffected sides. it takes about 15-20 minutes and is reliable for detecting sensory deficits post-stroke.

Other outcomes

  1. MoCA (Montreal Cognitive Assessment)

    Time frame: Assessment at baseline.

    The Montreal Cognitive Assessment (MoCA) is a one-page, 30-point cognitive screening measurement scale that takes about 10 minutes to administer. There are 12 subtasks in the MoCA test that include memory, visuospatial orientation, executive functioning, phonemic fluency, and two-item abstract thinking task, attention, concentration, and working memory, language, orientation to time and place. A score of 26 is a cutoff score to differentiate between normal and abnormal. The reliability of the MoCA-S was 0.89 and the intraclass correlation coefficient was 0.955.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Combined Effects of Accelerated Skill Acquisition Programme With Segmental Vibration on Extensor Muscles for Upper Limb Function in Subacute Stroke.

Acronym: ASAP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2025
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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