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| Name | Class |
|---|---|
| University of Medicine and Dentistry of New Jersey | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RT 300-P FES Cycle | Experimental | Participants exercised using functional electrical stimulation cycling (FES) using the RT 300-P FES cycle (Restorative Therapies, Baltimore, MD). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RT 300-P FES Cycle | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | pre- and post-intervention; time frame among participants ranged from 4 to 12 months |
| 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. | At entry until completion (range 4-14 months) (One participant's DEXA scan was obtained late due to illness) |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Castello, MD | Children's Specialized Hospital | Principal Investigator |
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Difficult to recruit because of transportation limitations
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | pre- and post-intervention; time frame among participants ranged from 4 to 12 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Difficulty for participants to attend sessions. Difficulties with recruitment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frank Castello | Children's Specialized Hospital | 732 258 7065 | fcastello@childrens-specialized.org |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. |
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| 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. | Posted | Jun 2011 | Mean | Standard Deviation | g/cm^2 | At entry until completion (range 4-14 months) (One participant's DEXA scan was obtained late due to illness) |
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| 0 |
| 6 |
| 0 |
| 6 |
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| D014947 | Wounds and Injuries |