Edited by: Saumyajit Basu, Park Clinic, India
Reviewed by: Harvinder Singh Chhabra, Indian Spinal Injuries Centre, India; Shankar Acharya, Sir Gangaram Hospital, India
*Correspondence: Seyed Mansoor Rayegani, Professor of Physical Medicine and Rehabilitation, Department of Physical Medicine and Rehabilitation, Shohada Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. e-mail:
This article was submitted to Frontiers in Spinal Cord Medicine, a specialty of Frontiers in Neurology.
This is an open-access article subject to a non-exclusive license between the authors and Frontiers Media SA, which permits use, distribution and reproduction in other forums, provided the original authors and source are credited and other Frontiers conditions are complied with.
Spinal cord injury (SCI) is one of the critical and devastating injuries. As time grows, SCI causes widespread disability and dysfunction (Braddom,
Physiotherapy, mechanical, and electrical equipments are usual methods prescribed for performing physical exercise in spinal cord injured patients, but they are time consuming and costly (Sköld et al.,
Even though there are numerous studies evaluating effect of functional electrical stimulation (FES) on muscle properties of SCI people, less research has focused on the benefits of passive cycling in the management of spasm and improving ROM of lower limbs in individuals with SCI (Sköld et al.,
Even though, SCI veterans are not suffering from geriatric sequelae, their physical condition and sedentary life style following the spinal injury makes cardiopulmonary disorders in veterans expectable. During active physical exercises, e.g., using EPPS, there will appear tachycardia, hypertension, and headache. Therefore, the exercise duration should be decreased and then again increased but gradually or even in some cases, unfortunately, quit the exercise. And this is one of several factors upon which we decided to conduct a research focusing on the usage method of EPS in veterans.
Furthermore; EPPS or electrical passive cycling has recently been applied for physical therapy in veterans; and as its effect on joints spasticity and electrodiagnosis parameters is not yet defined. Physical effects of EPPS usage in Iranian veterans with SCI had been studied in this trial and both objective and subjective signs in relation with EPCS/EPPS were assessed.
The present trial is a prospective clinical research performed on 64 SCI veterans.
According to the study method, all the SCI Veterans living in Tehran were invited to receive the Electric Passive Cycling equipment and to undergo clinical and electrodiagnostic tests by the assigned PM and R MDs of Shohada Hospital and JMERC (
The criteria upon which the subjects recruited were as per follow:
The participant should be with SCI and provided with the electric passive cycling system.
The Veteran should be willing to participate and cooperate in the study,
Exclusion criteria:
Lower limb fracture.
Any other orthopedic disease in lower limbs.
Inappropriate collaboration during the course of trial.
Before the initiation of the trial, written consent had been signed by each of the participants with above criteria.
In this randomized prospective clinical trial, 74 veterans were recruited during 2 years. After being visited by the PM&R MD and filling up the questionnaire of the veterans plan, they were provided with the required introductory letter to the delivering division temporarily established in the Research Center of Janbazan (veterans).
At the time, a simple randomization was performed, all patient with inclusion criteria were allocated by a random numbers and by using random number table to two groups: intervention (passive cycling) and control group (physical therapy). Equal allocation between two treatment arms were considered. Type of design was parallel group.
Routine physical therapy including stretching, ROM, and strengthening exercises were considered for control group. Thirty-seven veterans selected in control and intervention group during study period which was 2 months, eight patients from control were dropped from the study because they did not participate in physical therapy program regularly. Two patients from intervention group were dropped from the study due to inaccurate and irregular use if EPPS (Figure
Intervention group were placed in their own wheelchair in front of a motorized cycle (THERA-vital, Medica Medizin GmbH, Hochdorf, Germany). The veteran’s legs were passively moved in a standardized way by that motorized cycle for required period of time.
The method of exercise with the pedaling system were taught to the veterans, its probable risks and benefits, and the features of this research plan.
Gradual increase in the length of exercise to the target level of 20 min/set repeating three times a day was a guideline to be performed for 2 months.
Hence; SCI veterans were divided into two groups regarding cycling usage:
Group 1 (Control group) The veterans who did not use EPPS but just receive physical therapy for 2 months. (29 veterans); Group 2 (Intervention group) The veterans who used EPPS optimally/up to optimal level (35 veterans).
All patients were permitted to continue their previously activities including standing and walking with braces but were not permitted to participate in non-study-related lower extremity repetitive motion tasks or electrically stimulated exercise.
All veterans in intervention group signed informed consent forms, which was approved by the governing institutional review board.
Demographic information was obtained by interviewing with the patients. All data including clinical examination results, goniometric parameters, and electrodiagnostic findings (before and after intervention) were recorded in patients’ files.
Physical examination data, e.g., muscle strength (according to Kondal Scale; Braddom,
In order to measure the passive range of motion in joints, Goniometer was utilized.
Electrodiagnostic tests were conducted via a pair of two-channeled TOENNIES-PLUS, German made devices in the research and academic center. Electrodiagnosis was performed and reported by a PM&R MD.
The objective signs evaluated in veterans were as per follow: (1) Hip, knee, and ankle passive range of motion, (2) spasticity scale (according to Modified Ashworth Scale).
All clinical assessments were performed three times during the study: (1) at the first day of study, (2) 2 months later after finishing study protocol (passive cycling in group 1 and physical therapy in group 3) 1 year after finishing study protocol.
Finally, the results of clinical evaluations performed 1 year after finishing the study protocol were reported.
We performed the electrodiagnostic tests by a two channel synergy electrodiagnostic instrument
H-Reflex (LT&RT), Amplitude – Change
H (max)/M (max), H (max)/M (max) – change, H-Reflex (RT<), Onset Latency – Change
F – Wave – (RT<) – Consistency – Change, F-Wave – (RT<), Amplitude – Change.
The variables mentioned above had been measured three times during the trial: (1) at the first day of study (the same day that subjects were recruited), (2) 2 months later after finishing study protocol (passive cycling in group 1 and physical therapy in group (3) 1 year after finishing the period of the study, we commenced another series of electrodiagnostic tests in both associated centers and in both two groups with different therapy protocol. Each subject was examined by the exact PM&R MD who had visited them in the first phase last year.
Hence, the electrodiagnostic tests (at the first day of the study and after 1 year) were performed at the fixed time for all subjects.
Finally, the results of electrophysiologic tests performed 1 year after finishing the study protocol were reported.
In order to analyze the data resulted from the study, we utilized Paired
The participants included 93.5% male veterans and 4.7% female ones. The mean age of patients was 43 years old, while most of the cases (21 persons = 32.8%) had become SCI during 1985–1986.
All patients except one suffered from complete SCI. The involved body area included cervical injury in 11 subjects (17.2%), upper thoracic injury in 22 (34.4%), and lower thoracic injury in 29 (45.3%), and lumbar spinal injury in two patients (3.1%; Table
Spinal regions | Right | Left | ||||||
---|---|---|---|---|---|---|---|---|
Motor region of the spinal injury | Sensory region of the spinal injury | Motor region of the spinal injury | Sensory region of the spinal injury | |||||
No. | % | No. | % | No. | % | No. | % | |
Cervical | 11 | 17.2 | 8 | 12.5 | 12 | 18.8 | 8 | 12.5 |
Upper thoracic | 22 | 34.4 | 20 | 31.3 | 21 | 32.8 | 20 | 31.3 |
Lower thoracic | 29 | 45.3 | 28 | 43.8 | 28 | 43.8 | 28 | 43.8 |
Lumbar | 2 | 3.1 | 2 | 3.1 | 2 | 3.1 | 1 | 1.6 |
Unidentified | 0 | 0 | 0 | 0 | 1 | 1.6 | 7 | 10.9 |
Total | 64 | 100 | 64 | 100 | 64 | 100 | 64 | 100 |
One patient was categorized as being in ASIA B (Braddom,
The final results of spasticity and ROM change, also electrophysiologic tests performed 1 year after finishing the study protocol were presented here. We also measured all these parameters immediately after finishing study protocol (2 months after beginning of the study). However, as the results of 1 year follow up was the same as the results obtained immediately after completing 2 month study protocol, we reported the results of 1 year follow up.
In Group 1 who did not use the EPPS at all, there was shown no significant change in the mean Ashworth spasticity scale before and after launching the EPPS. Meanwhile, in Group 2 who had used the EPPS up to the optimal level, the mean Spasticity Scale before application of EPPS was more than the mean Spasticity Scale after EPPS usage (
In the group who did not use EPPS at all (Group 1) there was found no significant difference in mean ROM of hip (Add., Abd., Flex., Ext., Internal, and External Rotation), knee flexion, ankle dorsiflexion, and plantar flexion.
Finally, in Group 2 who used EPPS on an optimal basis, except for knee flexion, there was shown significant increase for ROM of hip (Abd, Add., Flex, and Ext), ankle dorsiflexion and plantar flexion (Table
Variant | Mean value | SD | ||
---|---|---|---|---|
Hip abd. ROM | Before EPPS | 18.9655 | 9.3902 | 0.003 |
After EPPS | 23.1034 | 7.6080 | ||
Hip add. ROM | Before EPPS | 15.8621 | 7.3276 | 0.005 |
After EPPS | 18.9655 | 5.5708 | ||
Hip flex. ROM | Before EPPS | 85.3448 | 22.2779 | 0.000 |
After EPPS | 103.7931 | 13.9933 | ||
Hip ext. ROM | Before EPPS | 7.4138 | 7.8627 | 0.000 |
After EPPS | 12.0690 | 6.1986 | ||
Knee flex ROM | Before EPPS | 89.3103 | 28.0218 | 0.111 |
After EPPS | 150.000 | 204.7646 | ||
Ankle dorsiflex ROM | Before EPPS | 3.5714 | 5.4189 | 0.000 |
After EPPS | 13.5714 | 6.2148 | ||
Ankle plantar flex | Before EPPS | 9.8214 | 10.2227 | 0.000 |
After EPPS | 19.2857 | 10.8622 |
In both intervention and control group, there was no significant difference in H-Reflex amplitude either before or after launching the EPPS.
There was a significant difference in decreasing H max/M max (RT<) and F/M ratio after versus before exercising with the electric passive cycling system among the veterans who had exercised to the target level (Table
Variables | Mean value | SD | |
---|---|---|---|
RT H (max)/M (max) 1 | 0.3984 | 0.1902 | 0.000 |
RT H (max)/M (max) 2 | 0.1963 | 0.1348 | |
LT H (max)/M (max) 1 | 0.4022 | 0.1828 | 0.000 |
LT H (max)/M (max) 2 | 0.1989 | 0.1176 | |
RTF/M ratio 1 | 0.2063 | 0.2631 | 0.027 |
RTF/M ratio 2 | 0.0923 | 0.1399 | |
LTF/M ratio 1 | 0.2036 | 0.2697 | 0.025 |
LTF/M ratio 2 | 0.0717 | 0.1043 |
Nevertheless, regarding other measured variables, there was no remarkable difference between those two groups.
Mean age for Iranian veterans participated in this study was 40–45 years old, which is considered young likewise other countries that SCI primarily affects young men (Braddom,
In our study, the most frequent level of injury was thoracic level. Hence; almost all of the SCI veterans in our study suffered from mostly complete lower limbs disability. According to international references, cervical spinal cord injuries occur more frequently than thoracic and lumbar injuries (Frontera,
The next issue is that, most of the veterans had been injured when the Iran–Iraq war was on its prime days, but they developed SCI complications gradually during 15–20 years after their primary injury at war days.
We assessed mainly objective signs in this study and it is to be emphasized that considering objective signs is significant because it crosses out the interference from patients, leading to the measurement of interventional factors and shows their crucial effect.
The ROM for lower limbs are of high significance in SCI veterans health condition since long term sedentary life leads to comparative stiffness in the joints (McArdle et al.,
In our study, in veterans who used EPPS on an optimal basis, significant increase for ROM of hip, ankle dorsiflexion, and plantar flexion were noticed, indicating effective role of EPPS on ROM of these joints.
However, no change in knee flexion ROM was noticed. There could be an explanation for that finding. In patients with optimum knee flexion from the very beginning of the trial, no alteration in ROM values was noticed and it was due to their original proper knee flexion. While those without proper knee flexion probably could not use EPPS properly and obtain appropriate results from exercising with EPPS.
In similar studies conducted to determine the effects of passive leg cycle exercise in patients with SCI, increased muscle force and torque output were observed in SCI patients (Hjeltnes et al.,
Long term FES cycling was shown to enhance fitness, decrease insulin resistance, and increase mass in persons with SCI (Braddom,
Even though there are numerous studies evaluating effect of FES on muscle properties of SCI people, less research has focused on the benefits of passive cycling in individuals with SCI (Kakebeeke et al.,
The mean spasticity scale in veterans who practiced with the pedaling device to the target level or below the target showed significant decrease in comparison with the spasticity scale before providing the electric passive cycling system. This is to show the significant effect of exercise with EPPS in decreasing the spasticity.
Passive rhythmic activities reported to improve Spasticity (Katz,
Regarding Electrodiagnostic findings, EPPS had no effects on reduction of H-Reflex and F-wave amplitudes in our study. This is against Rösche’s findings through his research. In his study, mean F-wave amplitude, mean F-wave/M-response ratio, and maximum F-wave/M-response ratio were significantly lower after utilizing a motorized exercise-cycle than before. Though it is to be emphasized that he had not evaluated the usage of EPPS for a long period of time (Rösche et al.,
Spinal cord injury subjects are prone to cardiovascular disorders leading to increased risk of mortality, due to their physical inactivity and dependency for mobility (Nuyens et al.,
In conclusion, We found beneficial physical effect of EPPS in our study represented in electrodiagnostic and other objective measures in SCI veterans. The spasticity level was reduced and passive ROM were also improved in SCI veterans used EPPS at optimal level. Furthermore, these positive effects 1 year after passive cycling was stopped, was similar to the results obtained immediately after 2 month passive cycling. Our results demonstrated that patients using EPPS gained better results compared with manual passive movements. EPPS is a method of achieving continues and regular passive movement, but stretching parameters like speed or smoothness of passive movement may not be controlled by manual stretching. We suggest that response to electrical passive cycling can be monitored via measuring electrophysiological parameters besides clinical spasticity measurement scales (Ashworth’s scale, etc.). Monitoring motor neuron excitability via measuring electrophysiologic parameters was also indicated in previous studies (Fox and Hitchcock,
We suggest to conduct more studies with larger samples for evaluating the effect of passive cycling on spasticity, ROM and other muscle properties.
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.