To determine the effectiveness of resisted exercises and electrical muscle stimulation in upper limbs muscle strength and bulk development in paraplegic patients.
Design
The study was conducted on a total sample of 52 participants divided into two groups; the control and the experimental. Randomized, superiority, parallel-group trial with blinded outcome assessment. Randomization was centralized and computerized with concealed randomization sequence carried out at an external site
Settings and conduct
Paraplegic Center Peshawar
Participants/Inclusion and exclusion criteria
Inclusion criteria:
If participants have a sustained spinal cord injury for four weeks and their primary rehabilitation is completed.
Aged between 18-30 years
Being able to give consent.
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.
Exclusion criteria:
If patients 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 fracture in the upper limb.
Intervention groups
Group 1:
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 total electrical stimulation time was 10 minutes for each Muscle.
Group 2:
This group were underwent resisted exercises for 8 weeks. During each training session 3 sets were performed. Every training session were started and ended at heart rate of 100 beats per minutes whereas stretching time of 5 minutes.
Main outcome variables
muscle strength and muscle bulk
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220524054977N2
Registration date:2022-09-13, 1401/06/22
Registration timing:retrospective
Last update:2022-09-13, 1401/06/22
Update count:0
Registration date
2022-09-13, 1401/06/22
Registrant information
Name
Wagma Wajid
Name of organization / entity
Rehman Medical Institute, Peshawar
Country
Pakistan
Phone
+92 91 5822632
Email address
wagma.wajid@rmi.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-03, 1400/10/13
Expected recruitment end date
2022-06-04, 1401/03/14
Actual recruitment start date
2022-01-07, 1400/10/17
Actual recruitment end date
2022-06-08, 1401/03/18
Trial completion date
2022-06-11, 1401/03/21
Scientific title
Effectiveness of Electrical Muscle Stimulation versus Resisted Exercises in upper limbs muscle Strength and bulk development in paraplegic patients
Public title
Effectiveness of Electrical Muscle Stimulation versus Resisted Exercises in upper limbs muscle Strength and bulk development in paraplegic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
52
Actual sample size reached:
52
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board (IRB) of Shifa Tameer-e-Millat University
Street address
Shifa International Hospitals Ltd، Gate No. 1، 4 Pitras Bukhari Rd, H 8/4 H-8, Islamabad, Islamabad Capital Territory
City
Islamabad
Postal code
44000
Approval date
2022-01-02, 1400/10/12
Ethics committee reference number
IRB#276-21
Health conditions studied
1
Description of health condition studied
Paraplagia
ICD-10 code
G82.2
ICD-10 code description
Paraplegia
Primary outcomes
1
Description
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
2
Description
Muscle size
Timepoint
Baseline and after 8 weeks of intervention
Method of measurement
Measuring Tape
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Paraplagic Center Peshawar
Full name of responsible person
Syed Muhammad Ilyas
Street address
Phase 4, Sector P 1، Street 10, Phase 4 Hayatabad, Peshawar, Khyber Pakhtunkhwa
City
Peshawar
Postal code
25000
Phone
+92 91 9217902
Email
nfo@paraplegiccenter.org
Web page address
https://paraplegiccenter.org/about-us/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shifa Tameer-e-millat university
Full name of responsible person
Syed Ali Hussain
Street address
Shifa International Hospitals Ltd، Gate No. 1، 4 Pitras Bukhari Rd, H 8/4 H-8, Islamabad, Islamabad Capital Territory
City
Islamabad
Postal code
44000
Phone
+92 51 8463382
Email
alihussain_dpt.ads@stmu.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shifa Tameer-e-millat university
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
shifa tameer-e-millat university
Full name of responsible person
Syed Ali Hussain
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Shifa International Hospitals Ltd، Gate No. 1، 4 Pitras Bukhari Rd, H 8/4 H-8, Islamabad, Islamabad Capital Territory
City
Islamabad
Province
Capital
Postal code
44000
Phone
+92 51 8438060
Email
alihussain_dpt.ads@stmu.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shifa Tameer-e-Millat University
Full name of responsible person
Habib Ullah
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Shifa International Hospitals Ltd، Gate No. 1، 4 Pitras Bukhari Rd, H 8/4 H-8, Islamabad, Islamabad Capital Territory
City
Islamabad
Province
Capital
Postal code
44000
Phone
+92 51 8438060
Email
habibullah65464@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shifa Tameer-e-Millat University
Full name of responsible person
Qaiser Khan
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Shifa International Hospitals Ltd، Gate No. 1، 4 Pitras Bukhari Rd, H 8/4 H-8, Islamabad, Islamabad Capital Territory
City
Islamabad
Province
Capital
Postal code
44000
Phone
+92 51 8438060
Email
qaiserkhan@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
To keep the privacy of the participants
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available