Clinical trial NCT05405140: Multiphasic Neuroplasticity Based Training Protocol With Shock Wave Therapy For Post Stroke Spasticity
Official title: Multiphasic Neuroplasticity Based Training Protocol With Shock Wave Therapy For Post Stroke Spasticity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Spasticity, Muscle
Keywords: Neuroplasticity,
Exercise
Stroke
post stroke spasticity
Electromyography
Ultrasonography
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified ashworh scale
timeFrame: 6th weeks
Secondary outcomes:
measure: Resting joint angle
timeFrame: 6th weeks
measure: EMG study
timeFrame: 6th weeks
measure: Ultrasonography
timeFrame: 6th weeks
measure: Time up and Go
timeFrame: 6th weeks
measure: Burg Balance scale
timeFrame: 6th weeks
measure: Functional independence measure
timeFrame: 6th weeks
measure: Barthal index
timeFrame: 6th weeks
measure: Rivermead Mobility Index
timeFrame: 6 week
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah international university
state: Punjab
Study officials:
affiliation: Riphah international university lahore campus
name: Rabiya Noor, PHD
role: PRINCIPAL_INVESTIGATOR
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