Walk-Training Program for Individuals With Chronic Spinal Cord Injury (SCI)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-04

Study Completion Date

2019-09-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Cardiovascular disease (CVD) is the common leading cause of death among people with spinal cord injury (SCI) and occurs at an early age in people with SCI as compared to able-bodied people. The findings are consistent in demonstrating a high prevalence of CVD among people with SCI. Lack of physical activity and/or prolonged sitting which is observed in people with SCI due to impaired/loss of motor function is associated with increased risk factors of CVD. By doing this study, researchers hope to learn the effects of walking training on cardiovascular health among people with chronic SCI.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Retraining Walking After Spinal Cord Injury

NCT00059553

Spinal Cord Injuries Quadriplegia Paraplegia +2 more

UNKNOWN PHASE2/PHASE3

Hybrid-FES Exercise to Prevent Cardiovascular Declines in Acute SCI

NCT02139436

Spinal Cord Injury

COMPLETED NA

The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury

NCT05542238

Spinal Cord Injuries Cardiovascular Abnormalities Cerebrovascular Disease; Sequelae +1 more

TERMINATED NA

An Exercise Intervention to Reduce Neuropathic Pain and Brain Inflammation After Spinal Cord Injury

NCT04137159

Spinal Cord Injuries

TERMINATED NA

Exercise for People with Spinal Cord Injury

NCT04007445

Spinal Cord Injuries

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Cord Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

Participants will undergo a walking program using a treadmill, a body-weight support system, and an assistive device.

Group Type EXPERIMENTAL

walking training

Intervention Type BEHAVIORAL

Participants will receive three sessions a week of BWSTT with assistive training device for 8 weeks; a total of 24 sessions. The duration of each training session will an hour. During walk-training, the participant will wear a harness which is attached to an overhead motorized lift to provide body-weight support and to prevent the risk of falling.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

walking training

Participants will receive three sessions a week of BWSTT with assistive training device for 8 weeks; a total of 24 sessions. The duration of each training session will an hour. During walk-training, the participant will wear a harness which is attached to an overhead motorized lift to provide body-weight support and to prevent the risk of falling.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Individuals between 18 and 60 years old, who have paraplegia (T1-L2) SCI, and who are scored less than 5 in Functional Independence Measure, Locomotion: Walk
* The onset of SCI must be one year or more at the beginning of the study
* Participants must not be participating in any other similar gait training activities
* Participants must have medical approval from their physician to participate in walk-training

Exclusion Criteria

* Major Cardiovascular diseases
* Other neurological diseases
* Muscle spasticity (greater than 3 according to Ashworth scale)
* Severe orthopedic issues such as joint stiffness and fractures
* Osteoporosis (bone mineral density T-score less than - 2.5)\[155\]
* Inflammatory diseases or infections
* Open wound and pressure ulcer
* Pregnant women
* Cognitive or psychiatric disorders
* Uncontrolled autonomic dysreflexia; sudden increase in blood pressure

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No