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The Effect of FES on Children With Spinal Cord Injury

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
RT 300-P FES Cycle
Sponsored by
Children's Specialized Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring pediatric spinal cord injury, FES cycling, bone mineral density, quality of life

Eligibility Criteria

4 Years - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    RT 300-P FES Cycle

    Arm Description

    Participants exercised using functional electrical stimulation cycling (FES) using the RT 300-P FES cycle (Restorative Therapies, Baltimore, MD).

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 10, 2006
    Last Updated
    August 10, 2012
    Sponsor
    Children's Specialized Hospital
    Collaborators
    University of Medicine and Dentistry of New Jersey
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00291317
    Brief Title
    The Effect of FES on Children With Spinal Cord Injury
    Official Title
    The Effect of FES on Children With Spinal Cord Dysfunction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    September 2008 (Actual)
    Study Completion Date
    January 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Children's Specialized Hospital
    Collaborators
    University of Medicine and Dentistry of New Jersey

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Cord Injury
    Keywords
    pediatric spinal cord injury, FES cycling, bone mineral density, quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    6 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    RT 300-P FES Cycle
    Arm Type
    Experimental
    Arm Description
    Participants exercised using functional electrical stimulation cycling (FES) using the RT 300-P FES cycle (Restorative Therapies, Baltimore, MD).
    Intervention Type
    Device
    Intervention Name(s)
    RT 300-P FES Cycle
    Other Intervention Name(s)
    FES (Functional electrical stimulation) cycling using th RT 300-P FES cycle, (Restorative Therapies, Baltimore, MD).
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0)Score.
    Description
    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
    Title
    Change in Bone Mineral Density Measured Via DEXA Scan
    Description
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Frank Castello, MD
    Organizational Affiliation
    Children's Specialized Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Effect of FES on Children With Spinal Cord Injury

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