Multiphasic Neuroplasticity Based Training Protocol With Shock Wave Therapy For Post Stroke Spasticity

Not Applicable

Completed

• Conditions: Stroke; Spasticity, Muscle
• Interventions: Other: Conventional physical therapy; Other: Shock wave therapy with multiphasic neuroplasticity based training protocol

• Registration Number: NCT05405140
• Lead Sponsor: Riphah International University

Brief Summary

this study will be conducted to f find the effects of multiphasic neuroplasticity based training protocol with Shock Wave Therapy on Neurophysiological, Morphological and Functional Parameters of Post Stroke Spasticity.

Detailed Description

Spasticity is a common sensory-motor dysfunction observed following a stroke. Spasticity is a velocity-dependent increase in resistance during a passive stretch due to hyper excitability of stretch reflex. This results in many functional impairments and patients centered problems. Given the complexity of spasticity related issues, its rehabilitation must entail comprehensive approach which address and synchronize spasticity reduction with motor function restoration without compensation. Shock Wave Therapy (SWT) is a non-invasive low cost devise gaining its use for spasticity reduction. After damage brain undergoes some sort of rearrangement. Literature says that during this period if it will rehabilitated through new pattern functional recovery can be optimized. However there is paucity of evidence for effectiveness of multiphasic neuroplasticity based Training protocol (MNTP) with SWT regarding its intensity frequency and specificity for spasticity management.

It will be a mix method approach. The patients after full filling the inclusion criteria , age ranging between 45 to 65 years having a stroke more than 3 months ago and having problematic spasticity interfering with function or causing a clinical problem, and no contraindications to shock wave therapy Upper or lower limb spasticity MAS ≥ 1 will be randomly assigned into four groups A,B,C,D. All groups will receive conventional rehabilitation training for 30 min per day five times a week for 4 weeks .Moreover patients in group A,BC also receive added SWT, MNTP and a combination of MNTP and SWT respectively. Motor recovery and spasticity will be using clinical (modified Asworth scale, Tardieu scale), neurophysiological, morphological(muscle ultrasound) and functional parameter( Fugl -meyer, burg balance, time up and go, Barthal index, Rivermeads mobility index ) at 0 , 8 and 16 week of treatment. The methodological approach used in this, will encompasses quantitative methods to assess program effectiveness and mixed methods to evaluate rehabilitation program components and aspects of protocol implementation. Qualitative methodology is needed to capture the range of participant experiences in the real- life clinical setting.

Study Timeline

• Study Start: 2022-05-20
• Study First Submitted: 2022-05-31
• Study First Submitted QC: 2022-05-31
• Study First Posted: 2022-06-06
• Primary Completion: 2023-08-15
• Study Completion: 2023-10-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• 40 - 70years.

  • Those had a stroke more than 3 months ago
  • Unilateral stroke
  • Able to participate in therapy regime or Participate in an ambulatory rehabilitation program.
  • They having problematic spasticity either focal or generalized.
  • Upper or lower limb spasticity (MAS ≥ 2) interfering with function or causing a clinical problem, and no contraindications to shock wave therapy.
  • if the improvement in spasticity is realistically expected
  • they will be considered suitable for to shock wave therapy
  • Minimental scale examination (MMSE).
  • Comprehensive Severity Index (CSI) for severity assessment.

Exclusion Criteria

• If they had had received treatment with BoNT-A within six months
• Will receiving intrathecal baclofen or other anti-spasticity medications
• If patients will be on to anticoagulants.
• had undergone neurolysis or surgery to the affected limb;
• had concomitant neurological conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional physical therapy	Conventional physical therapy	Stretching and strengthing and motor sensory motor training of effected side
Shock wave therapy with multiphasic neuroplasticity based training protocol	Shock wave therapy with multiphasic neuroplasticity based training protocol	Shock wave therapy with multiphasic neuroplasticity based training protocol based on motor relearning program and task oriented approach

Primary Outcome Measures

Name	Time	Method
Modified ashworh scale	6th weeks	Modified Ashworth Scale (MAS) is used to assess spasticity. Scoring is between 0 to 4 where 0 means no increase in muscle tone and 4 means limb is rigid in flexion or extension.

Secondary Outcome Measures

Name	Time	Method
EMG study	6th weeks	Fwave , H reflexElectrophysiological assessment, such as measurement of the reflex activities Spastic muscle: Ankle planter flexor, Knee flexor
Resting joint angle	6th weeks	Resting joint angle will showa the spasticity, the most the angle is narrow the more the mucle is spastic
Ultrasonography	6th weeks	to examine disruptions in the normative architecture of spastic muscles. Muscle length (MFL),Muscle thickness (MT) Muscle pennation angle
Time up and Go	6th weeks	To determine fall risk and measure the progress of balance, sit to stand and walking. ≤ 10 seconds = normal. ≤ 20 seconds = good mobility, can go out alone, mobile without gait aid. ≤ 30 seconds = problems, cannot go outside alone, requires gait aid. \* A score of ≥ 14 seconds has been shown to indicate high risk of falls.
Rivermead Mobility Index	6 week	The Rivermead Mobility Index assesses functional mobility in gait, balance and transfers after stroke. Items receive a score of 0 for a "No" response and 1 for a "Yes" response. Total scores are determined by summing the points for all items. A maximum of 15 points is possible; higher scores indicate better mobility performance. A score of "0" indicates an inability to perform any of the activities on the measure.
Burg Balance scale	6th weeks	It is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks A score of 56 indicates functional balance. A score of \< 45 indicates individuals may be at greater risk of falling.
Functional independence measure	6th weeks	The Functional Independence Measure (FIM) is an instrument that was developed as a measure of disability. The FIM's assessment of degree of disability depends on the patient's score in 18 categories, focusing on motor and cognitive function. Each category or item is rated on a 7-point scale (1 = \<25% independence; total assistance required, 7 = 100% independence)
Barthal index	6th weeks	The Barthel Scale/Index is an ordinal scale used to measure performance in activities of daily living (ADL). It uses ten variables describing ADL and mobility. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. The amount of time and physical assistance required to perform each item are used in determining the assigned value of each item. External factors within the environment affect the score of each item. If adaptations outside the standard home environment are met during assessment, the participant's score will be lower if these conditions are not available.

Trial Locations

Locations (1)

Riphah international university; 🇵🇰 Lahore, Punjab, Pakistan