The Effect of FES on Children With Spinal Cord Injury - Study Results

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Spinal Cord Injury
Intervention:	Device: RT 300-P FES Cycle

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Difficult to recruit because of transportation limitations

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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.

Description

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.

Participant Flow: Overall Study

	FES Cycle Exercise
STARTED	6
COMPLETED	6
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
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.

Description

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.

Baseline Measures

	FES Cycle Exercise
Number of Participants [units: participants]	6
Age [units: participants]
<=18 years	5
Between 18 and 65 years	1
>=65 years	0
Age [units: years] Mean ± Standard Deviation	16.57 ± 4.42
Gender [units: participants]
Female	3
Male	3
Region of Enrollment [units: participants]
United States	6

Outcome Measures

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1. Primary:

Change in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0)Score. [ Time Frame: pre- and post-intervention; time frame among participants ranged from 4 to 12 months ]

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2. Primary:

Change in Bone Mineral Density Measured Via DEXA Scan [ Time Frame: At entry until completion (range 4-14 months) (One participant's DEXA scan was obtained late due to illness) ]

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Serious Adverse Events

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Other Adverse Events

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