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IRCT20210615051585N1 IRCT 2021-07-01 Shifa Tameer e Millat University Comparisons of the effects of Baclofen, Transcutaneous Electrical Nerve Stimulation and sustain stretch for the treatment of spasticity in the traumatic spinal cord injury Spasticity Management in Spinal Cord Injury (SMSCI) Comparisons of the effects of Baclofen, Transcutaneous Electrical Nerve Stimulation and sustain stretch for the treatment of spasticity in the traumatic spinal cord injury 2021-03-12 anticipated 127 Complete https://irct.ir/trial/56885 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: N/A, Randomization description: Random assignment for traetment, Blinding description: Only the researcher doing the study knows which treatment or intervention the participant is receiving. It makes results less likely to be biased. N/A Traumatic Spinal Cord Injury. Intervention 1: Intervention group: Baclofen. Intervention 2: Intervention group: Transcutaneous Electrical Nerve Stimulation (TENS). Intervention 3: Intervention group: Sustain Stretch. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to Ethical Considerations
public Dr. Saima Gul
Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University
Islamabad Pakistan 44000 +92 51 8441751 saimaa.gul@gmail.com Shifa Tameer e Millat University scientific Dr. Saima Gul
House # 2 , Sector I-8 Islamabad
Islamabad Pakistan 44000 +92 332 1964158 saimaa.gul@gmail.com Shifa Tameer e Millat University Pakistan 1. Spasticity (Grade ≥1 and ≤4 as per MAS) 2. Have sustained a traumatic spinal cord injury a Minimum of 3 months before consent 3. Age = 20 - 45 years 20 years 45 years Both 1. Have chronic systemic diseases and have any other serious co-morbidity, e.g. hepatitis C, infections and Deep vein thrombosis etc. 2. Have extensive fixed contractures in the lower limb 3. Have any contraindications to Baclofen, TENS and sustain stretch such as experience clinically significant orthostatic Hypo-tension in response to electrical stimulation or allergies or Have a history of bone fracture or family history of fragility fractures Treatment - Drugs Treatment - Devices Rehabilitation Intervention group: Baclofen Intervention group: Transcutaneous Electrical Nerve Stimulation (TENS) Intervention group: Sustain Stretch Spasticity. Timepoint: baseline, 1st week, 2nd week, 3rd week & 4th week after intervention. Method of measurement: Modified Ashworth Scale. To determine the Range of Motion (ROM) of ankle joint. Timepoint: 4th week. Method of measurement: secondary outcome will be measured through Goniometer. N/A N/A Shifa Tameer e Millat University Approved 2021-05-18 Institutional Review Board and Ethics Committee (IRB and EC) Shifa International Hospital and Shifa Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University Islamabad Federal Pakistan