Aquatic vs. Land Locomotor Training Overground Locomotor Training in Improving Ambulatory Function and Health-Related Quality of Life (ALT)
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|ClinicalTrials.gov Identifier: NCT02774603|
Recruitment Status : Terminated (Due to lack of funding the study was terminated early)
First Posted : May 17, 2016
Last Update Posted : October 9, 2018
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
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.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Other: Aquatic Locomotor Training Other: Land Locomotor Training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Efficacy of Aquatic Locomotor Training Compared to Overground Locomotor Training in Improving Ambulatory Function and Health-Related Quality of Life|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||March 2018|
Active Comparator: Aquatic Locomotor Training
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
Active Comparator: Land Locomotor Training
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
- Change from Baseline 10 meter Walk Test at 4 months [ Time Frame: up to 16 weeks ]
- 6 Minute Walk Test [ Time Frame: up to 16 weeks ]
- Berg Balance Scale [ Time Frame: up to 16 weeks ]
- Health Survey on the Short Form 36 [ Time Frame: up to 16 weeks ]
- Quality of Life on the SCI QL-23 scale [ Time Frame: up to 16 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774603
|United States, Maryland|
|Cristina Sadowsky, M.D.|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Cristina Sadowsky, M.D.||Hugo W. Moser Research Institute at Kennedy Krieger, Inc.|