Improve Dynamic Lateral Balance of Humans With SCI

Spinal Cord Injury Clinical Trial

Official title:

Improve Dynamic Lateral Balance of Humans With SCI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02991248
• Other study ID #: R01HD083314
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: October 30, 2024

Study information

• Verified date: March 2023
• Source: Shirley Ryan AbilityLab
• Contact: Weena Dee, PT
• Phone: 312-2384824
• Email: wdee[@]ric.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to test whether pelvis perturbation training paired with transcutaneous spinal direct current stimulation (tsDCS) will be effective in improving dynamic balance and locomotor function in humans with SCI. One group will receive pelvis perturbation training paired with tsDCS, one group will receive pelvis perturbation training paired with sham, and one group will receive treadmill training only.

Description:

A major goal of patients with spinal cord injury (SCI) is to regain walking ability, as limitations in mobility can affect most activities of daily living. In addition, patients with SCI may experience a higher incidence of falls due to impaired balance and gait. Dynamic balance control plays a crucial role during locomotion in human SCI. Thus, improved dynamic balance may facilitate locomotion in this population. Current balance training paradigms can be effective in improving balance during standing, but are less effective in improving dynamic balance during locomotion in humans with SCI. Thus, there is a need to develop new paradigms for improving dynamic balance and locomotor function in patients with SCI. The goal of this study is to test whether pelvis perturbation training paired with transcutaneous spinal direct current stimulation (tsDCS) will be effective in improving dynamic balance and locomotor function in humans with SCI. We postulate that providing a perturbation force to the pelvis during treadmill training will increase the activation of muscles used for maintaining lateral balance while walking. Further, repeated activation of particular sensorimotor pathways may reinforce circuits and synapses used for lateral balance control through a use-dependent neural plasticity mechanism. However, the excitability of spinal cord neural circuitries may be depressed due to the reduced descending drive signals from the upper level control center after SCI, which may reduce the efficacy of neuralplastic changes achieved following rehabilitation. The excitability of neural pathways is crucial for neural reorganization achieved following rehabilitation. Recently studies indicate that tsDCS may modulate the excitability of neural circuitries of the spinal cord in patients with SCI. Thus, we postulate that controlled pelvis perturbation training paired with tsDCS will be more effective than that paired with a sham in improving dynamic balance and locomotor function in humans with SCI. Results obtained from this study will lead to an innovative clinical therapy aimed at improving balance and walking function in humans with SCI. Improvements in balance and walking function may allow for increased participation in community-based ambulation and activities, and significantly improve quality of life in humans with SCI.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: October 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. age between 18 and 65 years;

2. medically stable with medical clearance to participate;

3. level of the SCI lesion between C4-T10;

4. passive range of motion of the legs within functional limits of ambulation;

5. ability to walk on a treadmill for more than 20 minutes with partial body weight support as needed and short sitting/standing breaks;

6. ability to ambulate without orthotics or with orthotics that do not cross the knee for more than 10 meters

Exclusion Criteria:

1. the presence of unhealed decubiti, existing infection, severe cardiovascular and pulmonary disease, concomitant central or peripheral neurological injury (e.g. traumatic head injury or peripheral nerve damage in lower limbs);

2. history of recurrent fractures and/or known orthopedic injury to the lower extremities;

3. Botox injection within 6 months of starting the study, and current receiving physical therapy treatment;

4. have metallic implantation in the spinal region underneath where electrodes may be placed.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• robotic training
robotic training by applying pelvis force perturbation
• spinal cord electrical stimulation
Applying direct current electrical stimulation on spinal cord
• treadmill
conventional treadmill training only

Locations

Country	Name	City	State
United States	Abilitylab	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in overground gait speed from baseline	gait speed	post 6 weeks of training and 8 weeks after the end of training
Secondary	Changes in balance (BBS score) from baseline	Berg Balance Score	post 6 weeks of training and 8 weeks after the end of training
Secondary	Changes in dynamic gait index from baseline	Dynamic Gait Index	post 6 weeks of training and 8 weeks after the end of training
Secondary	Changes in 6 minutes walking distance from baseline	Walking distance in 6 minutes	post 6 weeks of training and 8 weeks after the end of training