Spinal Stimulation Sit-to-Stand Training After Spinal Cord Injury

NCT03536338 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2020-06-02

No results posted yet for this study

Summary

An injury to the spinal cord can be life altering: with a 'complete' injury, the affected individual is unable to move their legs at all and may become wheelchair-bound. While a 'complete' injury suggests that the cord was completely severed, it is actually more common for some connections in the spinal cord to remain after it is injured but, for some reason, they are inactive or sleeping.

Electrical stimulation applied to the skin surface at the lower back appears to 'wake up' these remaining connections, allowing some (previously unavailable) leg movements. The first time they had this spinal stimulation (SS), people with long-standing 'complete' spinal cord injuries became able to move their legs and, after several weeks of SS, these movements seemed to increase. They also noticed other changes taking place, including improvements in their bladder control.

SS has been shown to cause strong leg extension movements, and one person with SCI stood up with SS, using minimal support. SS for standing may assist people with SCI to carry out daily tasks at home, which would hugely benefit the SCI community.

In this study we will explore whether SS enables people with SCI to stand up and whether regular sit-to-stand training combined with SS improves; i) standing ability; ii) bladder control and; iii) well-being, in people with SCI.

Ten volunteers with SCI will carry out an 8-week sit-to-stand training programme. Training will be carried out 3 times/week at Neurokinex using their Keiser Power Rack. The volunteers will be randomly assigned either to the control (sit-to-stand only) or test (sit-to-stand plus SS) group. Measurements will be taken before and after the training programme to assess standing ability, bladder function, and well-being.

Conditions

  • Spinal Cord Injuries

Interventions

OTHER

Spinal Stimulation

transcutaneous electrical stimulation of the lumbar spinal cord during rehabilitation.

OTHER

Sit-to-stand Training

Rehabilitation of standing from a chair using the Keiser Rack

Sponsors & Collaborators

  • The Neurokinex Charitable Trust

    collaborator OTHER
  • Inspire Foundation

    collaborator UNKNOWN
  • Royal National Orthopaedic Hospital NHS Trust

    collaborator OTHER
  • University College, London

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-24
Primary Completion
2020-03-23
Completion
2020-03-23

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03536338 on ClinicalTrials.gov