Stroke Clinical Trial
Official title:
Multiphasic Neuroplasticity Based Training Protocol With Shock Wave Therapy For Post Stroke Spasticity
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.
Status | Recruiting |
Enrollment | 32 |
Est. completion date | October 15, 2023 |
Est. primary completion date | August 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Pakistan | Riphah international university | Lahore | Punjab |
Lead Sponsor | Collaborator |
---|---|
Riphah International University |
Pakistan,
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. — View Citation
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Modified ashworh scale | 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. | 6th weeks | |
Secondary | Resting joint angle | Resting joint angle will showa the spasticity, the most the angle is narrow the more the mucle is spastic | 6th weeks | |
Secondary | EMG study | Fwave , H reflexElectrophysiological assessment, such as measurement of the reflex activities Spastic muscle: Ankle planter flexor, Knee flexor | 6th weeks | |
Secondary | Ultrasonography | to examine disruptions in the normative architecture of spastic muscles. Muscle length (MFL),Muscle thickness (MT) Muscle pennation angle | 6th weeks | |
Secondary | Time up and Go | 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. | 6th weeks | |
Secondary | Burg Balance scale | 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. | 6th weeks | |
Secondary | Functional independence measure | 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) | 6th weeks | |
Secondary | Barthal index | 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. | 6th weeks | |
Secondary | Rivermead Mobility Index | 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. | 6 week |
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