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

Riphah International University

Status: Enrolling

Conditions: Spasticity, Muscle; Stroke

Treatments: Other: Shock wave therapy with multiphasic neuroplasticity based training protocol; Other: Conventional physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05405140

REC/RCR&AHS/22/1102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Shock wave therapy with multiphasic neuroplasticity based training protocol

Experimental group

Description:

Shock wave therapy with multiphasic neuroplasticity based training protocol based on motor relearning program and task oriented approach

Treatment:

Other: Shock wave therapy with multiphasic neuroplasticity based training protocol

Conventional physical therapy

Active Comparator group

Description:

Stretching and strengthing and motor sensory motor training of effected side

Treatment:

Other: Conventional physical therapy