Clinical trial NCT02774603: Aquatic vs. Land Locomotor Training Overground Locomotor Training in Improving Ambulatory Function and Health-Related Quality of Life
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
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Injury
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

Primary outcomes:
measure: Change from Baseline 10 meter Walk Test at 4 months
timeFrame: up to 16 weeks
Secondary outcomes:
measure: 6 Minute Walk Test
timeFrame: up to 16 weeks
measure: Berg Balance Scale
timeFrame: up to 16 weeks
measure: Health Survey on the Short Form 36
timeFrame: up to 16 weeks
measure: Quality of Life on the SCI QL-23 scale
timeFrame: up to 16 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Cristina Sadowsky, M.D.
state: Maryland
Study officials:
affiliation: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Cristina Sadowsky, M.D.
role: PRINCIPAL_INVESTIGATOR
References: