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Treadmill Training With Body Weight Support in Patients With Spinal Cord Injury

Primary Purpose

Spinal Cord Injury

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Body weight support treadmill training
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Locomotion, Spinal Cord Injury, Body Weight Supported Walking

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria for Patients with Chronic Injury: Spinal cord injury at or above the T10 spine 1 year post injury Some volitional movement in one or both limbs (i.e., motor incomplete) Ability to stand with limited bracing Ability to rise from sit to stand with no more that moderate assistance Inclusion Criteria for Patients with Subacute Injury: Spinal cord injury at or above the T10 spine 2 to 8 months post injury Volitional movement in at least one lower limb muscle (i.e., motor incomplete), although may not be capable of unsupported standing or moving from sit-to-stand without maximal assistance Exclusion Criteria: Fractures at or below T11 Neoplastic, degenerative, or vascular disorders of the spine or spinal cord Significant orthopaedic conditions that would interfere with regular exercise or rehabilitation therapy Decubitus ulcer Advanced urinary tract infection Medical conditions that increase the probability of having a seizure in response to single pulse transcranial magnetic stimulation

Sites / Locations

  • Upstate Medical UniversityRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 23, 2003
Last Updated
June 23, 2005
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00061295
Brief Title
Treadmill Training With Body Weight Support in Patients With Spinal Cord Injury
Official Title
Body Weight Supported Ambulation Training After Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
March 2003
Overall Recruitment Status
Unknown status
Study Start Date
March 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. Study Description

Brief Summary
Body weight support (BWS) treadmill training uses an overhead harness to give partial support to patients walking on a treadmill. This study will determine whether BWS training is more effective than conventional rehabilitation therapy in improving walking ability in patients with spinal cord injuries (SCI).
Detailed Description
Gait rehabilitation is a specific component of physical rehabilitation of persons with sub-acute or chronic spinal cord injury (SCI). One novel method of gait rehabilitation involves the use of an overhead support point and a harness. The BWS strategy has been combined with treadmill-based gait training in recent studies with dramatic results. It is believed that this form of training may enhance output of a 'central pattern generator' of stepping movement from circuitry intrinsic to the patient's spinal cord. However, only limited attention has been paid to the role that training-induced physical conditioning might play in mediating functional improvements. This study will evaluate whether BWS gait training is more effective than conventional rehabilitation therapy in improving functional gait in patients with neurologically incomplete spinal cord injury. The study will also compare treadmill-based training to overground-based training. Treadmill-based training has the inherent advantage of providing highly rhythmic input to the subject's legs; overground-based training has the inherent advantage of allowing use of assistive devices and thereby replicating a more 'natural' training condition. Patients with chronic SCI (greater than 1 year post-injury) and patients with sub-acute SCI (2 to 8 months post-injury) will be evaluated. Patients with chronic SCI will be randomly assigned to one of 3 groups: body weight support and treadmill-based training, body weight support and overground training, and conventional rehabilitation therapy. Patients with sub-acute injury will be randomized to receive either BWS treadmill training or conventional rehabilitation. Training sessions are typically 1 hour long, with 3 sessions per week for 13 weeks. All patients will be evaluated with a battery of functional, metabolic, and neurophysiologic measures prior to the onset of training and during the week after training has been completed. The primary outcome measure will be average maximum overground walking velocity without body weight support but with the use of passive assistive devices. Secondary measures will concentrate on function (balance, mobility), fitness (work capacity, strength, gait efficiency), and spinal cord neurophysiology (motor conduction, reflex excitability).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Locomotion, Spinal Cord Injury, Body Weight Supported Walking

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Body weight support treadmill training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for Patients with Chronic Injury: Spinal cord injury at or above the T10 spine 1 year post injury Some volitional movement in one or both limbs (i.e., motor incomplete) Ability to stand with limited bracing Ability to rise from sit to stand with no more that moderate assistance Inclusion Criteria for Patients with Subacute Injury: Spinal cord injury at or above the T10 spine 2 to 8 months post injury Volitional movement in at least one lower limb muscle (i.e., motor incomplete), although may not be capable of unsupported standing or moving from sit-to-stand without maximal assistance Exclusion Criteria: Fractures at or below T11 Neoplastic, degenerative, or vascular disorders of the spine or spinal cord Significant orthopaedic conditions that would interfere with regular exercise or rehabilitation therapy Decubitus ulcer Advanced urinary tract infection Medical conditions that increase the probability of having a seizure in response to single pulse transcranial magnetic stimulation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Blair M. Calancie
Phone
305-585-8347
Email
bcalancie@miamiproj.med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blair M. Calancie
Organizational Affiliation
University of Miami Project to Cure Paralysis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Upstate Medical University
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Treadmill Training With Body Weight Support in Patients With Spinal Cord Injury

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