Improving Gait in Patients With Spinal Cord Injuries

Status Completed

Clinical Trial Summary

This study is part of a larger clinical trial that examines the potential of a 12-week treadmill-training program to improve walking in patients with spinal cord injuries (SCIs). Patients in the trial are at least 1 year past their injury. This substudy tests a combination of two strategies to enhance the treadmill training program: electrically stimulating a muscle withdrawal reflex and providing body weight support by partially suspending patients as they walk on the treadmill.

Clinical Trial Description

Patients with spastic paresis due to incomplete SCI have inadequate motor control of the lower extremities that results in a number of abnormalities of movement. Among these are unregulated spinal reflexes, inadequate and delayed motor recruitment, and balance deficits. If the patient can walk, these abnormalities manifest in a gait pattern that has poorly coordinated timing between different muscle groups, decreased weight bearing capacity, and inappropriate muscle activity, such as scissoring.

Research in patients with SCIs has demonstrated that, despite the damage to the spinal cord, many of the nervous system pathways that control walking remain intact and can be activated by the proper sensory stimulation. Two technologies that may enhance the benefits of treadmill walking are body weight support (BWS) and functional electrical stimulation (FES). Preliminary studies indicate that by combining these two interventions, gait performance is improved such that more efficient and functional movement emerges. This study will evaluate the benefits of adding BWS and FES to a treadmill-training program for patients with SCIs.

During the treadmill training, patients are suspended in an apparatus to provide partial body weight support (BWS). The training effects of BWS locomotion with FES over the course of a multi-session training program will be examined. Study visits will be scheduled 3 days each week for 12 weeks. Participants will have follow-up visits at Months 3 and 12. Gait parameters modified by training will be identified and the nature of these changes will be characterized. Specifically, walking speed, kinematics, electromyography (EMG), and muscle strength will be assessed. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Spinal Cord Injuries

Clinical Trial Details

NCT number	NCT00060983
Study type	Interventional
Source	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact
Status	Completed
Phase	Phase 2
Start date	May 1998
Completion date	April 2002

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT06321172` - Muscle and Bone Changes After 6 Months of FES Cycling	N/A
Completed	`NCT03457714` - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting	`NCT05484557` - Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury	N/A
Suspended	`NCT05542238` - The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury	N/A
Recruiting	`NCT05503316` - The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System	N/A
Not yet recruiting	`NCT05506657` - Early Intervention to Promote Return to Work for People With Spinal Cord Injury	N/A
Recruiting	`NCT04105114` - Transformation of Paralysis to Stepping	Early Phase 1
Recruiting	`NCT03680872` - Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System	N/A
Completed	`NCT04221373` - Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation	N/A
Completed	`NCT00116337` - Spinal Cord Stimulation to Restore Cough	N/A
Completed	`NCT03898700` - Coaching for Caregivers of Children With Spinal Cord Injury	N/A
Recruiting	`NCT04883463` - Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury	N/A
Active, not recruiting	`NCT04881565` - Losing Balance to Prevent Falls After Spinal Cord Injury (RBT+FES)	N/A
Completed	`NCT04864262` - Photovoice for Spinal Cord Injury to Prevent Falls	N/A
Recruiting	`NCT04007380` - Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI	N/A
Active, not recruiting	`NCT04544761` - Resilience in Persons Following Spinal Cord Injury
Completed	`NCT03220451` - Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients	N/A
Terminated	`NCT03170557` - Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation	N/A
Recruiting	`NCT04811235` - Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial	N/A
Recruiting	`NCT04736849` - Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.