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Aquatic vs. Land Locomotor Training Overground Locomotor Training in Improving Ambulatory Function and Health-Related Quality of Life (ALT)

Primary Purpose

Spinal Cord Injury

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aquatic Locomotor Training
Land Locomotor Training
Sponsored by
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age between 18-65 years
  2. Cervical level (C1-C7) SCI of traumatic origin
  3. Motor incomplete SCI (ASIA Impairment Scale C or D)
  4. Chronic SCI, >12 months
  5. Age between 18 to 65 years
  6. Functional Status

i. Overground ambulator (able to walk at least 10 m with or without an assistive device)

ii. Able to demonstrate active movement at/or below L2 myotome

iii. Able to demonstrate adequate head control

1. Voluntarily extend head while positioned in harness

iv. Tolerance to activity

1. Participant able to tolerate up to 1 hour of standing without experiencing symptoms of orthostatic hypotension

g. Range of motion

i. PROM values for ankle dorsiflexion

1. Neutral positioning, 0○

ii. PROM values for knee extension

1. Up to -10○

iii. PROM values for hip extension

1. Neutral positioning, 0○

h. Height

i. Participant with minimum height of 48"

i. Weight

i. Participant with minimum weight of (to be determined based on therapist's clinical judgment)

ii. Participant with maximum weight of 300 lb

j. Participants are able to comply with procedures and follow up

k. Participants are medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues

l. Participants are legally able to make their own health care decisions

Exclusion Criteria:

a. Medical Complications i. Fracture

1. Participant with presence of unhealed fracture ii. Physician hold for medical reasons that the Principle Investigator will judge and decide on a case by case basis as a potential safety threat to the participant

  1. Wounds a. Allowed if physician cleared i. Excluded wounds likely to be present in areas enclosed with harness, present in areas that require access for facilitation, present in areas of direct weight bearing during LT session b. Wounds allowed must be fully covered with gauze then opsite (waterproof bandage) before Aquatic Locomotor Training
  2. Comorbidities a. E.g. poorly controlled diabetes, uncontrolled seizures, etc.
  3. Orthostatic hypotension

    a. Participant demonstrates symptomatic orthostatic hypotension that limits activity

  4. Uncontrolled autonomic dysreflexia symptoms a. Episode of uncontrolled autonomic dysreflexia symptoms within the past 1 month iii. Diarrhea iv. Mechanical ventilation v. Pacemakers vi. Central lines vii. Women who are pregnant, confirmed by a urine pregnancy test that will be done on all menstruating, or non-menopausal women viii. History of neurological disease ix. Non English speaking participants will not be targeted b. Currently undergoing, or have received Aquatic Locomotor Training or overground Locomotor Training within four weeks of the study start date (see above in 4d for further details)

Sites / Locations

  • Cristina Sadowsky, M.D.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Aquatic Locomotor Training

Land Locomotor Training

Arm Description

Aquatic Locomotor Training is a Locomotor Training technique utilizing an underwater treadmill to help increase a patient's independence and function. Aquatic Locomotor Training may require up to three people to obtain desirable gait kinematics: one at each of the patient's legs, and one at the patient's pelvis; however, typically with ambulatory patients, only one therapist is utilized. Therapists are highly trained, using their legs and feet to provide properly timed underwater cues throughout the gait cycle.

Locomotor Training encompasses a variety of interventions ranging from BWSTT to overground gait training to robotic-assisted walk training. Overground Locomotor Training, depending upon the technique used, can require up to four people to complete the intervention (one at each participant's leg, one at the participant's trunk and/or pelvis, and one monitoring the computer and/or treadmill).

Outcomes

Primary Outcome Measures

Change from Baseline 10 meter Walk Test at 4 months

Secondary Outcome Measures

6 Minute Walk Test
Berg Balance Scale
Health Survey on the Short Form 36
Quality of Life on the SCI QL-23 scale

Full Information

First Posted
May 12, 2016
Last Updated
October 5, 2018
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02774603
Brief Title
Aquatic vs. Land Locomotor Training Overground Locomotor Training in Improving Ambulatory Function and Health-Related Quality of Life
Acronym
ALT
Official Title
The Efficacy of Aquatic Locomotor Training Compared to Overground Locomotor Training in Improving Ambulatory Function and Health-Related Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Due to lack of funding the study was terminated early
Study Start Date
June 2015 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

4. Oversight

5. Study Description

Brief Summary
The aim of this study is to define and evaluate the efficacy of Aquatic Locomotor Training (ALT) compared to overground Locomotor Training in improving ambulatory function and health-related quality of life. The investigators hypothesize, that Aquatic Locomotor Training is capable of producing outcomes that are as good as, or better than, overground Locomotor Training. Aquatic Locomotor Training may be another tool for therapists to utilize for clinical improvements in function and gait for the Spinal Cord Injury (SCI) population. To determine the efficacy of Aquatic Locomotor Training on improving rehabilitation outcomes among patients with incomplete traumatic cervical Spinal Cord Injury by assessing these parameters: Walking speed and endurance Functional balance and fall risk HRQoL To describe the feasibility of conducting Aquatic Locomotor Training as an Locomotor Training modality for the rehabilitation of patients with incomplete traumatic cervical Spinal Cord Injury.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aquatic Locomotor Training
Arm Type
Active Comparator
Arm Description
Aquatic Locomotor Training is a Locomotor Training technique utilizing an underwater treadmill to help increase a patient's independence and function. Aquatic Locomotor Training may require up to three people to obtain desirable gait kinematics: one at each of the patient's legs, and one at the patient's pelvis; however, typically with ambulatory patients, only one therapist is utilized. Therapists are highly trained, using their legs and feet to provide properly timed underwater cues throughout the gait cycle.
Arm Title
Land Locomotor Training
Arm Type
Active Comparator
Arm Description
Locomotor Training encompasses a variety of interventions ranging from BWSTT to overground gait training to robotic-assisted walk training. Overground Locomotor Training, depending upon the technique used, can require up to four people to complete the intervention (one at each participant's leg, one at the participant's trunk and/or pelvis, and one monitoring the computer and/or treadmill).
Intervention Type
Other
Intervention Name(s)
Aquatic Locomotor Training
Intervention Type
Other
Intervention Name(s)
Land Locomotor Training
Primary Outcome Measure Information:
Title
Change from Baseline 10 meter Walk Test at 4 months
Time Frame
up to 16 weeks
Secondary Outcome Measure Information:
Title
6 Minute Walk Test
Time Frame
up to 16 weeks
Title
Berg Balance Scale
Time Frame
up to 16 weeks
Title
Health Survey on the Short Form 36
Time Frame
up to 16 weeks
Title
Quality of Life on the SCI QL-23 scale
Time Frame
up to 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18-65 years Cervical level (C1-C7) SCI of traumatic origin Motor incomplete SCI (ASIA Impairment Scale C or D) Chronic SCI, >12 months Age between 18 to 65 years Functional Status i. Overground ambulator (able to walk at least 10 m with or without an assistive device) ii. Able to demonstrate active movement at/or below L2 myotome iii. Able to demonstrate adequate head control 1. Voluntarily extend head while positioned in harness iv. Tolerance to activity 1. Participant able to tolerate up to 1 hour of standing without experiencing symptoms of orthostatic hypotension g. Range of motion i. PROM values for ankle dorsiflexion 1. Neutral positioning, 0○ ii. PROM values for knee extension 1. Up to -10○ iii. PROM values for hip extension 1. Neutral positioning, 0○ h. Height i. Participant with minimum height of 48" i. Weight i. Participant with minimum weight of (to be determined based on therapist's clinical judgment) ii. Participant with maximum weight of 300 lb j. Participants are able to comply with procedures and follow up k. Participants are medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues l. Participants are legally able to make their own health care decisions Exclusion Criteria: a. Medical Complications i. Fracture 1. Participant with presence of unhealed fracture ii. Physician hold for medical reasons that the Principle Investigator will judge and decide on a case by case basis as a potential safety threat to the participant Wounds a. Allowed if physician cleared i. Excluded wounds likely to be present in areas enclosed with harness, present in areas that require access for facilitation, present in areas of direct weight bearing during LT session b. Wounds allowed must be fully covered with gauze then opsite (waterproof bandage) before Aquatic Locomotor Training Comorbidities a. E.g. poorly controlled diabetes, uncontrolled seizures, etc. Orthostatic hypotension a. Participant demonstrates symptomatic orthostatic hypotension that limits activity Uncontrolled autonomic dysreflexia symptoms a. Episode of uncontrolled autonomic dysreflexia symptoms within the past 1 month iii. Diarrhea iv. Mechanical ventilation v. Pacemakers vi. Central lines vii. Women who are pregnant, confirmed by a urine pregnancy test that will be done on all menstruating, or non-menopausal women viii. History of neurological disease ix. Non English speaking participants will not be targeted b. Currently undergoing, or have received Aquatic Locomotor Training or overground Locomotor Training within four weeks of the study start date (see above in 4d for further details)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina Sadowsky, M.D.
Organizational Affiliation
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cristina Sadowsky, M.D.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

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Aquatic vs. Land Locomotor Training Overground Locomotor Training in Improving Ambulatory Function and Health-Related Quality of Life

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