Task-specificity for Locomotor Recovery Following SCI
Primary Purpose
Spinal Cord Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Variable Stepping Training
Variable Non-specific Training
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries
Eligibility Criteria
Inclusion Criteria:
- individuals with chronic (>1 yr duration) motor iSCI at the level or T10 (anatomical) or above
- ages 18-75 years
- ability to walk without physical assistance but with below-knee braces and assistive devices as needed
- self-selected gait speeds between 0.01-1.0 m/s.
- not currently receiving physical therapy
Exclusion Criteria:
- uncontrolled cardiopulmonary or metabolic disease that limits exercise participation
- active heterotopic ossification
- recurrent history of lower extremity fractures
- previous orthopedic or other peripheral or central neurological injury that may impair locomotor function
- history of botulinum toxin injection < 3 months prior
- Patients who are prescribed intrathecal or oral anti-spastics should agree to limit changes in anti-spastic use throughout the training and testing period.
Sites / Locations
- Rehabilitation Hospital of Indiana
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Variable Stepping Training
Variable Non-specific Training
Arm Description
High intensity stepping training in multiple environments, including overground, on a treadmill and on stairs.
High intensity non-stepping training, including balance, strength, and cycling tasks
Outcomes
Primary Outcome Measures
Walking Speed
fastest comfortable walking speed over short distances
Secondary Outcome Measures
Walking Distance
distance covered over 6 minutes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03144388
Brief Title
Task-specificity for Locomotor Recovery Following SCI
Official Title
Task-specificity for Locomotor Recovery Following SCI
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary goal of the proposed study is to identify the contributions of the amount of task-specific practice on locomotor (i.e., walking) recovery in patients with chronic (> 1 yr) motor incomplete spinal cord injury (iSCI). Consistent with principles of motor learning and exercise physiology, the investigators contend that certain training (i.e., dosage) parameters of physical rehabilitation are critical to mobility outcomes following neurological injury. Specifically, the specificity, amount and intensity of physical interventions (i.e., practice) may influence specific outcomes in the patient population treated. In ambulatory patients with iSCI, there are very few studies that have controlled for or targeted these training variables or their influence on locomotor recovery. Previous work suggests these training parameters may influence locomotor recovery in patients with other neurological disorders (i.e., stroke), although few studies have attempted to delineate similar contributions of in iSCI. Indeed, no studies have carefully controlled the amount of task-specific practice during physical rehabilitation of patients with iSCI, and such interventions are rarely utilized in the clinical setting. The goal of the present study is to delineate the relative contributions of amount of task-specific training on locomotor outcomes in individuals with iSCI. Using a cross-over, randomized clinical trial design, the investigators anticipated non-specific (i.e., non-stepping) training activities would result in smaller improvements as compared to task-specific (stepping) training. The investigators will investigate the effects of such training on walking performance and kinematics, as well as the impairments thought to contribute to walking performance. Successful completion of this project could have an immediate impact on rehabilitation research and treatment of people following iSCI, and may be utilized to treat more subacute patients with iSCI or other acute-onset neurological disorders.
Detailed Description
The primary goal of the proposed study is to identify the contributions of the amount of task-specific practice on locomotor (i.e., walking) recovery in patients with chronic (> 1 yr) motor incomplete spinal cord injury (iSCI). The investigators will do this by building on previous work directed towards identifying the essential exercise training parameters that maximize locomotor recovery. Consistent with principles of motor learning and exercise physiology, the investigators contend that certain training (i.e., dosage) parameters of physical rehabilitation, including the type (specificity) and amount of task practice, are critical to mobility outcomes following neurological injury. Previous work suggests these training parameters may influence locomotor recovery in patients with other neurological disorders (i.e., stroke), although few studies have attempted to delineate similar contributions of amount of task-specific practice in iSCI. Indeed, no studies have carefully controlled these training parameters during physical rehabilitation of patients with iSCI, and such interventions are rarely utilized in the clinical setting.
Reasons for these knowledge gaps from other rehabilitation studies to patients with iSCI or lack of clinical implementation are unclear, but may be due to adherence to traditional rehabilitation theories. One concern is that practicing only stepping tasks reduces attention towards hallmark physical impairments following iSCI, such as loss of strength or postural stability, which are considered primary determinants of decreased mobility. Only a few studies have addressed whether providing only structured stepping training can mitigate these impairments without their explicit practice, but not in the iSCI population. A related concern is that focused stepping training without significant attention towards impairments or gait quality may exaggerate altered movement strategies, which could be reinforced with repeated practice. However, there is little data to suggest "worsening" of abnormal gait patterns following high intensity training. Rather, recent findings suggest patients demonstrate more normal kinematics. If focused task specific (i.e., stepping) training is to be applied clinically, the investigators must delineate its contributions towards improving locomotor function, and their effects on underlying impairments and gait kinematics.
The central hypotheses are that stepping training in iSCI results in:1) greater locomotor gains as compared to non-specific interventions; 2) gains in selected impairments underlying gait dysfunction (i.e., strength and metabolic capacity and efficiency); and, 3) improvements in gait quality. To test these hypotheses, the proposed crossover, assessor-blinded, randomized clinical trial (RCT) is designed to test the effects of specificity of rehabilitation training applied early-post-stroke. In this RCT, patients > 1 year post-iSCI will be allocated to 4-6 weeks (20 session) of high-intensity stepping training or high-intensity non-specific training. Importantly, training intensity will be held constant to account for this potential confounding factor. Blinded assessments will be performed prior to and following each training paradigm. The investigators will address 3 specific aims:
Specific Aim 1: Demonstrate that high intensity stepping training in patients with chronic iSCI produces greater locomotor gains as compared to high intensity non-specific training strategies.
Hypothesis 1: High intensity stepping training will result in greater increases in gait speeds and distances Specific Aim 2: Test the effects of these training strategies on impairments and non-locomotor mobility tasks.
Hypothesis 2: Higher intensity stepping training groups will result in greater gains in metabolic capacity and efficiency.
Specific Aim 3: Analyze the potential effects of high intensity stepping or non-specific training on gait quality.
Hypothesis 3: High intensity training will result in improved sagittal-plane gait kinematics consistent with normal locomotor function, due in part to greater locomotor speeds, as compared to non-specific training strategies.
The aims represent an innovative approach to improving long-term mobility outcomes of patients with iSCI by applying selected principles of motor learning and exercise physiology yet untested in this population. Expected outcomes will be demonstration of the efficacy of a high intensity stepping training paradigm, with further understanding of potential underlying mechanisms and movement strategies used with improved locomotor performance. Successful completion of this project could have an immediate impact on rehabilitation research and treatment of people following iSCI, and may be utilized to treat more subacute patients with iSCI
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel-group with optional crossover
Masking
Outcomes Assessor
Masking Description
Blinded assessors at each measurement
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Variable Stepping Training
Arm Type
Experimental
Arm Description
High intensity stepping training in multiple environments, including overground, on a treadmill and on stairs.
Arm Title
Variable Non-specific Training
Arm Type
Active Comparator
Arm Description
High intensity non-stepping training, including balance, strength, and cycling tasks
Intervention Type
Procedure
Intervention Name(s)
Variable Stepping Training
Intervention Description
Six weeks (20 sessions) of high intensity stepping training in multiple variable environments
Intervention Type
Procedure
Intervention Name(s)
Variable Non-specific Training
Intervention Description
Six weeks (20 sessions) of high intensity stepping training in multiple variable environments
Primary Outcome Measure Information:
Title
Walking Speed
Description
fastest comfortable walking speed over short distances
Time Frame
change in walking speed from baseline testing to post-testing following 6 weeks of training
Secondary Outcome Measure Information:
Title
Walking Distance
Description
distance covered over 6 minutes
Time Frame
change in walking speed from baseline testing to post-testing following 6 weeks of training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
individuals with chronic (>1 yr duration) motor iSCI at the level or T10 (anatomical) or above
ages 18-75 years
ability to walk without physical assistance but with below-knee braces and assistive devices as needed
self-selected gait speeds between 0.01-1.0 m/s.
not currently receiving physical therapy
Exclusion Criteria:
uncontrolled cardiopulmonary or metabolic disease that limits exercise participation
active heterotopic ossification
recurrent history of lower extremity fractures
previous orthopedic or other peripheral or central neurological injury that may impair locomotor function
history of botulinum toxin injection < 3 months prior
Patients who are prescribed intrathecal or oral anti-spastics should agree to limit changes in anti-spastic use throughout the training and testing period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Hornby
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Hospital of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254-2607
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data available as requested
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Task-specificity for Locomotor Recovery Following SCI
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