NCT01407354

Brief Summary

Many people with spinal cord injury (SCI) hold some ability to move their leg muscles, and are therefore considered to demonstrate a motor incomplete injury. After such a spinal cord injury, individuals are able to walk less both in their home and in their community. De-conditioning, or a lack of endurance and fitness also occurs. Several methods are available to try to improve walking ability and the fitness of persons with motor incomplete spinal cord injury. This study examines two of these methods. The first is the use of robotically assisted body-weight supported walking using a device called the Lokomat. The second is aquatic or pool-based exercise. The investigators are researching the impact of these two techniques on walking ability and fitness in people who experienced motor incomplete spinal cord injury for at least 12 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 2, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

April 8, 2016

Completed
Last Updated

May 26, 2021

Status Verified

May 1, 2021

Enrollment Period

3 years

First QC Date

July 12, 2011

Results QC Date

April 6, 2016

Last Update Submit

May 6, 2021

Conditions

Spinal Cord Injury

Keywords

robotic weight supportaquatic exerciseincomplete motor spinal cord injuryASIA C and D

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Demonstrating 10% Change: Arm Ergometer and Lokomat Metabolic Cart VO2 Peak

    Peak VO2 via Arm Ergometer and Lokomat with metabolic cart

    7 months

Secondary Outcomes (1)

  • Number of Movement Recorded by Activity Monitor (SAM)

    7 months

Study Arms (2)

Lokomat Training

EXPERIMENTAL

Lokomat robotic assisted treadmill training Lokomat Treadmill Training

Device: Lokomat treadmill training

Aquatic Therapy

ACTIVE COMPARATOR

Aquatic exercise therapy

Other: Aquatic exercise therapy

Interventions

Lokomat treadmill trainingDEVICE

Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session

Also known as: Robotic Body Weight Supported Locomotor Training
Lokomat Training
Aquatic exercise therapyOTHER

Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session

Also known as: Aquatic Therapy
Aquatic Therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 years
  • Level of injury between C4 and T12 based on ASIA classification
  • Chronic (greater than 12 months) spinal injury
  • Completion of all conventional inpatient rehabilitation therapy
  • Motor incomplete spinal cord injury (AIS C or D)
  • Competency to provide informed consent
  • Ability to tolerate a standing frame for at least 30 minutes

You may not qualify if:

  • Currently performing aquatic therapy or Lokomat training as part of clinical care
  • Complete or concurrent lower motor neuron injury as defined by the absence of reflexes bilaterally at the knees and the ankles
  • Uncontrolled seizures
  • Skin opening greater than 2 cm in diameter
  • Alcohol consumption \> 3 oz liquor, or 3 x 4oz of wine, or 36 oz of beer per day
  • Cardiac history of (a) unstable angina, (b) recent (\< 3 months) myocardial infarction, (c) congestive heart failure (NYHA category II), or (d) hemodynamically significant valvular dysfunction
  • Medical history of (a) recent hospitalization for severe disease or surgery, (b)undiagnosed diabetics (fasting glucose \> 120) or poorly controlled diabetics (those not on a stable regimen for \>6 months) unable to be controlled with medical treatment, (c) significant orthopedic or chronic pain conditions limiting exercise, (d) active neoplastic disease, (e) pulmonary or renal disease, and (f) presence of any serious medical condition with a prognosis for death or dependency in the next 2 months
  • History of long bone fracture in the legs
  • Frequent bouts of autonomic dysreflexia (as determined by the principal investigator)
  • Any other medical co-morbidities that based on the judgment of the local principal investigator would preclude safe participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shepherd Center, Virginia C. Crawford Research Institute

Atlanta, Georgia, 30309-1465, United States

Location

University of Maryland Rehabilitation & Orthopaedic Institute (formerly known as Kernan Hospital)

Baltimore, Maryland, 21207, United States

Location

Related Publications (1)

  • Gorman PH, Scott W, VanHiel L, Tansey KE, Sweatman WM, Geigle PR. Comparison of peak oxygen consumption response to aquatic and robotic therapy in individuals with chronic motor incomplete spinal cord injury: a randomized controlled trial. Spinal Cord. 2019 Jun;57(6):471-481. doi: 10.1038/s41393-019-0239-7. Epub 2019 Jan 18.

    PMID: 30659286DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Aquatic Therapy

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Results Point of Contact

Title
Paula Richley Geigle PT PhD
Organization
University Maryland Rehabilitation and Orthopaedic Institute
pgeigle@umm.edu
410 448 6773

Study Officials

  • Paula R Geigle, PT, PhD

    University of Maryland Rehabilitation and Orthopaedic Institute

    PRINCIPAL INVESTIGATOR

  • Peter H Gorman, MD, FAAN

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Neurology

Study Record Dates

First Submitted

July 12, 2011

First Posted

August 2, 2011

Study Start

April 1, 2011

Primary Completion

April 1, 2014

Study Completion

July 1, 2014

Last Updated

May 26, 2021

Results First Posted

April 8, 2016

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)