Ignite Creation Date:
2024-05-05 @ 11:45 PM
Last Modification Date:
2024-10-26 @ 10:39 AM
Study NCT ID:
NCT01407354
Status:
COMPLETED
Last Update Posted:
2021-05-26
First Post:
2011-07-12
Brief Title:
Comparison of Lokomat and Aquatic Exercise for Individuals With Chronic Incomplete Spinal Cord Injury
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Lokomat and Aquatic Therapy in Chronic Motor Incomplete Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
This research will occur in two centers Kernan Orthopedics and Rehabilitation Hospital in Baltimore Maryland and Shepherd Center in Atlanta Georgia A total of 36 volunteers over a three year period are needed In order to qualify for this study individuals must be 18 to 65 years old with a motor incomplete SCI The level of injury can range from the fourth cervical level in the neck to the twelfth thoracic level in the back Potential volunteers must be able to tolerate standing in a standing frame for at least 30 minutes Individuals will be assessed by a physician to determine their eligibility for the study and if participating in this type of exercise would be safe Participants must be able to understand the study requirements and sign an informed consent document
Participants will need to commit to a total of seven months Included in this time is testing then the 3 months of exercise testing 2 week break then the second 3 months of exercise and a final testing Half of the group will start with the Lokomat training and half will start wtih aquatic exercise Each group will then switch to the other exercise condition Exercise sessions will occur three times per week and last approximately 45-55 minutes A physical therapist will provide personal direction for each of the exercise groups Walking ability and cardiovascular fitness as well as muscle strength will be assessed before starting exercise at the three-month point and then at the six month point
It is hoped that that this type of exercise therapy will help individuals with motor incomplete spinal injury both walk better and experience better heart-lung fitness and endurance The risks associated with this type of study are similar to any type of cardiovascular exercise In addition individuals with spinal cord injury may present with some medical conditions there may be other risks of the study The physicians and therapists involved in the research will discuss these risks in detail with the individuals who enroll
This type of research is important to better understand how best to prescribe exercise treatments to people with spinal injury This is especially true with regards to aquatic therapy since there is very little scientific data on its effect in this group of individuals The rigorous assessment of aquatic exercise which is already available in many communities may expand the fitness opportunities for individuals with incomplete spinal cord injury
Participants will need to commit to a total of seven months Included in this time is testing then the 3 months of exercise testing 2 week break then the second 3 months of exercise and a final testing Half of the group will start with the Lokomat training and half will start wtih aquatic exercise Each group will then switch to the other exercise condition Exercise sessions will occur three times per week and last approximately 45-55 minutes A physical therapist will provide personal direction for each of the exercise groups Walking ability and cardiovascular fitness as well as muscle strength will be assessed before starting exercise at the three-month point and then at the six month point
It is hoped that that this type of exercise therapy will help individuals with motor incomplete spinal injury both walk better and experience better heart-lung fitness and endurance The risks associated with this type of study are similar to any type of cardiovascular exercise In addition individuals with spinal cord injury may present with some medical conditions there may be other risks of the study The physicians and therapists involved in the research will discuss these risks in detail with the individuals who enroll
This type of research is important to better understand how best to prescribe exercise treatments to people with spinal injury This is especially true with regards to aquatic therapy since there is very little scientific data on its effect in this group of individuals The rigorous assessment of aquatic exercise which is already available in many communities may expand the fitness opportunities for individuals with incomplete spinal cord injury
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SC090147 | None | None | None |