Spinal Cord Injury
Conditions
Keywords
pediatric spinal cord injury, FES cycling, bone mineral density, quality of life
Brief summary
Regular exercise is strongly recommended to help maintain a healthy lifestyle. Unfortunately, children and young adults with damaged spinal cords may not be able to exercise regularly. However, there is an exercise bike specially designed for persons with damaged spinal cords that enables them to pedal by directly stimulating the muscles in their legs. Our study is designed to determine the benefits of exercise for Spinal Cord Injured (SCI) patients using this bike.
Detailed description
The inability to walk due to spinal cord dysfunction has profound effects on patients, both physiologically and psychologically. Complications associated with walking upright include loss of muscle mass from atrophy, reduction in bone mineral density (osteoporosis), compromised cardiovascular endurance, loss of sense of well-being, etc. Functional Electrical Stimulation (FES) of the lower extremities has been found to reverse many of these complications. We propose to examine the use of FES in children who have suffered from spinal cord injury (SCI). We plan to examine the effect of FES bike therapy on bone mineral density and psychological well-being.
Interventions
DEVICERT 300-P FES Cycle
Participants exercised using functional electrical stimulation cycling (FES) using the RT 300-P FES cycle (Restorative Therapies, Baltimore, MD). Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes per session over a 9 month period. The intervention was provided at Children's Specialized Hospital in Mountainside, and families were required to provide their own transportation. During the study, the participants continued to participate in their standard, primary rehabilitation program.
Sponsors
University of Medicine and Dentistry of New Jersey
Children's Specialized Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 21 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 4-21 * Paralysis/lack of sensation in lower extremities due to spinal cord injury.
Exclusion criteria
* Diseases known to affect bone metabolism * A history of hip or knee dislocation or subluxation * The presence of pressure sores in the areas of treatment * The presence of metallic hardware in the femur * A history of peripheral nerve injury, lower motor neuron disease, or chronic corticosteroid use; or a seizure disorder requiring pharmacological antiepileptic therapy that can affect bone mineral density. * Individuals with pacemaker devices or unhealed fractures also were excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0)Score. | pre- and post-intervention; time frame among participants ranged from 4 to 12 months | The PedsQL™ 4.0 is a modular instrument for measuring health-related quality of life in children and adolescents. The questionnaire asks how much of a problem each item has been during the past month, using a 5-point response scale. This study used the Emotional Functioning, Social Functioning, and School Functioning modules. Scores on these three modules are combined to yield a Psychosocial Health Summary Score (range = 0-100 with 100 being the maximum positive outcome). Pre- and post-intervention scores were compared to determine improvement. |
| Change in Bone Mineral Density Measured Via DEXA Scan | At entry until completion (range 4-14 months) (One participant's DEXA scan was obtained late due to illness) | Bone mineral density (BMD) was measured with Dual X-ray Absorptiometry (DEXA) scans using a GE LUNAR system. DEXA has been used in patients with loss of ambulation due to SCI to monitor changes in body composition over time and to evaluate the effectiveness of exercise in preventing or reducing the disease-related complications of SCI. It was used in the present study to determine BMD in the right distal femur at baseline; after 3 months of intervention; after 6 months; and for children who biked for the full duration of the study, at the completion of 9 months of intervention. |
Participant flow
Recruitment details
Difficult to recruit because of transportation limitations
Participants by arm
| Arm | Count |
|---|---|
| FES Cycle Exercise Participants exercised using functional electrical stimulation cycling (FES) using the RT 300 FES cycle (Restorative Therapies, Baltimore, MD). Stimulation rpm (45-50), pulse duration (250 μs), and frequency (33.3 Hz) were fixed. Amplitude ranged from 70-120mA, and average stim ranged from 16.50-29.7 μC. Participants were monitored for autonomic dysreflexia during training. Blood pressure and heart rate were monitored during the initial evaluation and the first session of cycling. Once it was established that there were no adverse physiological responses, ongoing blood pressure and heart rate monitoring did not continue for subsequent sessions. No participant experienced a dysreflexive episode in response to electrical stimulation during this study. Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes (plus a 2 minute warm up and 30 second cool down) per session over a 9 month period. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | FES Cycle Exercise |
|---|---|
| Age, Categorical <=18 years | 5 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age Continuous | 16.57 years STANDARD_DEVIATION 4.42 |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Change in Bone Mineral Density Measured Via DEXA Scan
Bone mineral density (BMD) was measured with Dual X-ray Absorptiometry (DEXA) scans using a GE LUNAR system. DEXA has been used in patients with loss of ambulation due to SCI to monitor changes in body composition over time and to evaluate the effectiveness of exercise in preventing or reducing the disease-related complications of SCI. It was used in the present study to determine BMD in the right distal femur at baseline; after 3 months of intervention; after 6 months; and for children who biked for the full duration of the study, at the completion of 9 months of intervention.
Time frame: At entry until completion (range 4-14 months) (One participant's DEXA scan was obtained late due to illness)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FES Cycle Exercise | Change in Bone Mineral Density Measured Via DEXA Scan | 0.062 g/cm^2 | Standard Deviation 0.11 |
Primary
Change in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0)Score.
The PedsQL™ 4.0 is a modular instrument for measuring health-related quality of life in children and adolescents. The questionnaire asks how much of a problem each item has been during the past month, using a 5-point response scale. This study used the Emotional Functioning, Social Functioning, and School Functioning modules. Scores on these three modules are combined to yield a Psychosocial Health Summary Score (range = 0-100 with 100 being the maximum positive outcome). Pre- and post-intervention scores were compared to determine improvement.
Time frame: pre- and post-intervention; time frame among participants ranged from 4 to 12 months
Population: Four of the six participants completed the PedsQL on at least 2 occasions. At minimum, each completed the PedsQL at their initial evaluation before beginning the cycling program and at or following their last cycling session.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FES Cycle Exercise | Change in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0)Score. | 7.08 units on a scale | Standard Deviation 8.21 |