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

Spinal Cord Injury Clinical Trial

— ALT  

Official title:

The Efficacy of Aquatic Locomotor Training Compared to Overground Locomotor Training in Improving Ambulatory Function and Health-Related Quality of Life

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02774603
• Other study ID #: IRB00066544
• Status: Terminated
• Phase: N/A
• Start date: June 2015
• Est. completion date: March 2018

Study information

• Verified date: October 2018
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Other:
• Aquatic Locomotor Training

• Land Locomotor Training

Locations

Country	Name	City	State
United States	Cristina Sadowsky, M.D.	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline 10 meter Walk Test at 4 months		up to 16 weeks
Secondary	6 Minute Walk Test		up to 16 weeks
Secondary	Berg Balance Scale		up to 16 weeks
Secondary	Health Survey on the Short Form 36		up to 16 weeks
Secondary	Quality of Life on the SCI QL-23 scale		up to 16 weeks