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IRCT20220524054977N2 IRCT 2022-09-13 Shifa Tameer-e-millat university Effectiveness of Electrical Muscle Stimulation versus Resisted Exercises in upper limbs muscle Strength and bulk development in paraplegic patients Effectiveness of Electrical Muscle Stimulation versus Resisted Exercises in upper limbs muscle Strength and bulk development in paraplegic patients 2022-01-03 anticipated 52 Complete https://irct.ir/trial/65747 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After patients are selected and baseline similarities are assessed, they will be randomly allocated to the control group and experimental group using the sealed envolpe method, Blinding description: Due to the nature of the study, it will not be feasible to blind the researcher/therapist and subjects. However, the assessor, who will assess pre and post scores, will be blinded. N/A Paraplagia. Intervention 1: Intervention group: This group was provided with electrical muscle stimulation intervention. Participants undergone the overall treatment session for two months (8 weeks) and 3 days per week. The targeted muscles for electrical stimulation were bicep brachi and triceps brachi. The parameters were as follows, frequency 45 Hertz, Biphasic Symmetrical Square wave with10 second on and 20 second off time. Ramp up time was 3 second, while ramp down timeWas 3 seconds. We used Comfy Stim EV-806 for muscle stimulation. Synchronous Stimulation was applied. The total electrical stimulation time was 10 minutes for each Muscle. The intensity at which tetanic contraction was elicited was used. Two of the EMS electrodes pad was placed on belly and insertion of Bicep muscles and then on Triceps muscles respectively. Intervention 2: Control group: This group were underwent resisted exercises for 8 weeks. The maximum strength of participants was assessed by one repetition maximum before and after the training session. Two exercises were included: Seated chest press involving pectoralis major and pectoralis minor, triceps brachii and deltoid muscles and Seated arm pull involving latissimus dorsi, trapezius, teres major and minor, rhomboids, deltoids, biceps brachii and brachialis, triceps brachii, pectoralis major and minor, and serratus anterior muscles. During each training session 3 sets were performed. The intensity of these sets was 80% of one repetition maximum. In first and second set, 8 repetitions were performed of two included exercises. In next third set patient will perform repetitions up to muscle fatigue level. If patient were able to perform 12 or more repetitions while performing third set, then work load were increased 5-10% for next treatment session. Two minutes’ rest was given after each set performed and 5-minute rest in between both exercises. The concentric and eccentric phases of resistance will last for 3 second each. Every training session were started and ended at heart rate of 100 beats per minutes whereas stretching time of 5 minutes. No - There is not a plan to make this available Justification or reason for not sharing IPD is To keep the privacy of the participants
public Syed Ali Hussain
Shifa International Hospitals Ltd، Gate No. 1، 4 Pitras Bukhari Rd, H 8/4 H-8, Islamabad, Islamabad Capital Territory
Islamabad Pakistan 44000 +92 51 8438060 alihussain_dpt.ads@stmu.edu.pk shifa tameer-e-millat university scientific Habib Ullah
Shifa International Hospitals Ltd، Gate No. 1، 4 Pitras Bukhari Rd, H 8/4 H-8, Islamabad, Islamabad Capital Territory
Islamabad Pakistan 44000 +92 51 8438060 habibullah65464@gmail.com Shifa Tameer-e-Millat University Pakistan If participants have a sustained spinal cord injury from four weeks and their primary rehabilitation is completed Age including 18-30 years Participants that are able to give consent Participants that are labeled by their physician as fit and can undertake exercise training program Ischemic stroke of MCA subjects suffering from stroke for at least 6 months 18 years 30 years Both If the patient will have Brachial plexus, peripheral nerve injury or current surgery of upper limb since last 2 months According to the National Pressure Ulcer Advisory Panel classification. Have stage 3 or 4 sacral ulcer Have any bone disorder e.g. such as Paget’s disease, senile osteoporosis etc Have a long-term history of fractures in the upper limb. Have a family history of weakened fractures Suffering from chronic systemic diseases, e.g. hepatitis C or HIV-AIDS Have fixed contractures in the upper extremity Have already pain in upper limb due to any other cause rather than SCI Are likely to experience autonomic hyperreflexia Could suffer from orthostatic hypotension as a result of electrical muscle stimulation Have any other serious medical conditions like malignancies, psychiatric problems G82.2 Paraplegia Rehabilitation Rehabilitation Intervention group: This group was provided with electrical muscle stimulation intervention. Participants undergone the overall treatment session for two months (8 weeks) and 3 days per week. The targeted muscles for electrical stimulation were bicep brachi and triceps brachi. The parameters were as follows, frequency 45 Hertz, Biphasic Symmetrical Square wave with10 second on and 20 second off time. Ramp up time was 3 second, while ramp down timeWas 3 seconds. We used Comfy Stim EV-806 for muscle stimulation. Synchronous Stimulation was applied. The total electrical stimulation time was 10 minutes for each Muscle. The intensity at which tetanic contraction was elicited was used. Two of the EMS electrodes pad was placed on belly and insertion of Bicep muscles and then on Triceps muscles respectively. Control group: This group were underwent resisted exercises for 8 weeks. The maximum strength of participants was assessed by one repetition maximum before and after the training session. Two exercises were included: Seated chest press involving pectoralis major and pectoralis minor, triceps brachii and deltoid muscles and Seated arm pull involving latissimus dorsi, trapezius, teres major and minor, rhomboids, deltoids, biceps brachii and brachialis, triceps brachii, pectoralis major and minor, and serratus anterior muscles. During each training session 3 sets were performed. The intensity of these sets was 80% of one repetition maximum. In first and second set, 8 repetitions were performed of two included exercises. In next third set patient will perform repetitions up to muscle fatigue level. If patient were able to perform 12 or more repetitions while performing third set, then work load were increased 5-10% for next treatment session. Two minutes’ rest was given after each set performed and 5-minute rest in between both exercises. The concentric and eccentric phases of resistance will last for 3 second each. Every training session were started and ended at heart rate of 100 beats per minutes whereas stretching time of 5 minutes. Muscle Strength. Timepoint: Before intervention, as baseline, and after 8 weeks of intervention. Method of measurement: 3.3.1 MMT (manual muscle testing) or Oxford Scale. Muscle size. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: Measuring Tape. Shifa Tameer-e-millat university Approved 2022-01-02 Institutional Review Board (IRB) of Shifa Tameer-e-Millat University Shifa International Hospitals Ltd، Gate No. 1، 4 Pitras Bukhari Rd, H 8/4 H-8, Islamabad, Islamabad Capital Territory Islamabad Capital Pakistan