Spinal Cord InjuryALTNCT02774603
Aquatic vs. Land Locomotor Training Overground Locomotor Training in Improving Ambulatory Function and Health-Related Quality of Life
A study testing Aquatic Locomotor Training and Land Locomotor Training in people with Spinal Cord Injury, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Aquatic Locomotor Training and Land Locomotor Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 27Show fewer
- Overground ambulator (able to walk at least 10 m with or without an assistive device)
- Able to demonstrate active movement at/or below L2 myotome
- Able to demonstrate adequate head control
- 1. Voluntarily extend head while positioned in harness
- Tolerance to activity
- 1. Participant able to tolerate up to 1 hour of standing without experiencing symptoms of orthostatic hypotension
- Range of motion
- PROM values for ankle dorsiflexion
- 1. Neutral positioning, 0○
- PROM values for knee extension
- 1. Up to -10○
- PROM values for hip extension
- 1. Neutral positioning, 0○
- Height
- Participant with minimum height of 48"
- Weight
- Participant with minimum weight of (to be determined based on therapist's clinical judgment)
- Participant with maximum weight of 300 lb
- Participants are able to comply with procedures and follow up
- Participants are medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues
- Participants are legally able to make their own health care decisions
Who cannot join
- 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
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Aquatic Locomotor Training Compared to Overground Locomotor Training in Improving Ambulatory Function and Health-Related Quality of Life
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.
Read more
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.
- Conditions
- Spinal Cord Injury
- Being tested
- Aquatic Locomotor Training, Land Locomotor Training
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic Locomotor TrainingOther
Land Locomotor TrainingOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Land Locomotor Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline 10 meter Walk Test at 4 months
Measured: up to 16 weeks
Secondary outcomes (4)
6 Minute Walk Test
Measured: up to 16 weeks
Berg Balance Scale
Measured: up to 16 weeks
Health Survey on the Short Form 36
Measured: up to 16 weeks
Quality of Life on the SCI QL-23 scale
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startJun 2015
- Primary completionMar 2018
- Study completionMar 2018
Why it stopped: Due to lack of funding the study was terminated early
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Sadowsky, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Investigators
- Cristina Sadowsky, M.D., Principal investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774603
- Sponsor's protocol ID
- IRB00066544
- Acronym
- ALT
- Status last verified
- Oct 2018
- First submitted
- 12 May 2016
- Last updated
- 9 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Aquatic Locomotor Training Compared to Overground Locomotor Training in Improving Ambulatory Function and Health-Related Quality of Life
- ClinicalTrials.gov ID
- NCT02774603
- Acronym / sponsor ID
- ALT / IRB00066544
- Conditions
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to lack of funding the study was terminated early
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Study start
- Jun 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 17 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aquatic Locomotor Training | Active comparator | Other: Aquatic Locomotor TrainingAquatic 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. |
| Land Locomotor Training | Active comparator | Other: Land Locomotor TrainingLocomotor 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquatic Locomotor Training | Other | Aquatic Locomotor Training |
| Land Locomotor Training | Other | Land Locomotor Training |
Primary outcome
Change from Baseline 10 meter Walk Test at 4 months
Time frame: up to 16 weeks
4 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Due to lack of funding the study was terminated early). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Sadowsky, M.D. principal investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic Locomotor Training and Land Locomotor Training in people with Spinal Cord Injury, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to lack of funding the study was terminated early). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline 10 meter Walk Test at 4 months (time frame: up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.