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Effects of Functional Electrical Stimulation-cycling Plus Progressive Resistance Training on Muscle Strength After Incomplete Spinal Cord Injury: A Randomized Controlled Trial

Effects of Functional Electrical Stimulation-cycling Plus Progressive Resistance Training on Muscle Strength After Incomplete Spinal Cord Injury: A Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000670471
Enrollment
21
Registered
2016-05-23
Start date
2015-04-01
Completion date
2015-06-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A spinal cord injury (SCI) is a chronic health condition in which the individual loses certain functions, no longer being able to exercise them in the same way as before the injury (Vall, Mauricio, Costa, Pereira, & Friesen, 2011). SCI can induce prolonged inactivity and subsequent secondary complications such as muscle atrophy, pressure ulcers, and demineralization of the lower limb bones (Yoshida et al., 2013). Patients who survive with SCI often left with considerable residual disability that require longterm care for hospitalization, rehablitation and home care services (Wyndaele & Wyndaele, 2006). In United states, the incidence of SCI is approximately 40 cases per million population per year. The average age at time of injury is 31.7 years, with teenagers and young adults having the greatest risk (Livecchi, 2011). However, in Malaysia among all survivors of SCI about 50% of the patients experienced severe SCI (ASIA A or B), mainly involving patients in the age group 16 to 45 and experiencing traumatic SCI (Ibrahim et al., 2013). Musculoskeletal atrophy is a serious complication of SCI which contributes to the development of secondary impairements in spinal cord injured individuals. Although better medical care of persons with SCI has helped to progressively improve their health and life expectancy over the last six decades, gains in mobility and self-care skills have remained relatively stagnant because further improvements in these areas are dependent on advancements in basic science that may lead to reversal of the neurological loss (Ragnarsson, 2008). Thus, it is well accepted among healthcare professionals and now diplomats worldwide that regular physical activity is a cornerstone of physical and psychologic well-being. Since the 1960s, FES-induced muscle contractions have been widely used as a rehabilitation therapy or an exercise regimen for the paralyzed lower limbs of people with SCI. With FES, paralyzed legs can be artificially evoked to produce otherwise unattainable dynamic movements, such as cycling, rowing, knee extension, standing, and stepping (Davis, Hamzaid, & Fornusek, 2008). On the basis of this observation, FES cycle ergometers have been designed and extensively tested and prescribed for persons with SCI based on established clinical benefits. It can be performed either as static muscle contractions and dynamic knee extension (Hettinga & Andrews, 2008). FES-LCE did improve muscular strength and endurance, increase exercise Performance, and improve cardiovarcular response (Thrasher, Ward, & Fisher, 2013 ; Davis et al, 2008). However, the persistance of the result from the exercise training still unknown. Therefore, in this study the objective is to investigate the effects of FES-cycling ergometer plus progression resistance exercise on muscle strength and cardiovascular response among incomplete SCI patient.

Interventions

The intervention group will receive 12 weeks Functional Electrical Stimulation (FES)-cycling (twice a week) plus progressive resistance training (once a week) which will be conducted by physiotherapist at research lab, University Malaya Medical Center, Kuala Lumpur. Each session for FES-cycling will be in a small group in 1 hour in duration which include electrodes to the quadriceps, hamstring, tibialis anterior and gastrocnemius while using Motomed cycling model VIVA 2 Parkinson which synchroni

The intervention group will receive 12 weeks Functional Electrical Stimulation (FES)-cycling (twice a week) plus progressive resistance training (once a week) which will be conducted by physiotherapist at research lab, University Malaya Medical Center, Kuala Lumpur. Each session for FES-cycling will be in a small group in 1 hour in duration which include electrodes to the quadriceps, hamstring, tibialis anterior and gastrocnemius while using Motomed cycling model VIVA 2 Parkinson which synchronize with Hasomed Rehamove 2 a FES machine during gait cycling. The parameters will be set with 300 microsecond pulse width, 30 Hz frequency, 35 rpm speed and 70-140 mA intensity. The participant will be register for attendance every training session. The progressive resistance training involve electrodes on quadriceps, hamstring, tibialis anterior and gastrocnemius while using biodex isokinetic machine model no 850-230 which synchronize with Rehastim a portable FES. The resistance training on biodex machine will be based on manufacturer program which consist of 3-4 sets of resistance training with 10 repetitions at 50% RM and 5-10 second hold each repetition for 30 minutes. The number of sets will be progress at 70% RM at 6 weeks then to 100% RM at 10 weeks as determined by physiotherapist.

Sponsors

High Impact Research Grant, University Malaya, Kuala Lumpur
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

over 2 years incomplete SCI. ASIA C and D only Level of injury C4-T12 Have at least 90 degree knee range of motion Able to response to FES Able to follow command

Exclusion criteria

Had recent history of trauma to the lower limb Severe of infected skin pressure sore on weight-bearing skin areas Uncontrolled spasticity or pain History of cardiovascular problem History of cardiorespiratory problem Metal implants in femur or tibia bone

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026