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

NCT02774603 | Terminated

• 1 other identifier: IRB00066544
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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:

1. 1.Walking speed and endurance
2. 2.Functional balance and fall risk
3. 3.HRQoL

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• Change from Baseline 10 meter Walk Test at 4 months

  up to 16 weeks

Secondary Outcomes (4)

• 6 Minute Walk Test

  up to 16 weeks

• Berg Balance Scale

  up to 16 weeks

• Health Survey on the Short Form 36

  up to 16 weeks

• Quality of Life on the SCI QL-23 scale

  up to 16 weeks

Study Arms (2)

Aquatic Locomotor Training

ACTIVE COMPARATOR

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.

Other: Aquatic Locomotor Training

Land Locomotor Training

ACTIVE COMPARATOR

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).

Other: Land Locomotor Training

Interventions

Aquatic Locomotor Training OTHER

Aquatic Locomotor Training

Land Locomotor Training OTHER

Land Locomotor Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \. Voluntarily extend head while positioned in harness
• iv. Tolerance to activity
• \. 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
• \. Neutral positioning, 0○

You may not qualify if:

• a. Medical Complications i. Fracture
• \. 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)

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead

Study Sites (1)

Cristina Sadowsky, M.D.

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Cristina Sadowsky, M.D.

  Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Director, Physician

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 17, 2016
• Study Start: June 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

US (1)