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Spinal Stimulation Sit-to-Stand Training After Spinal Cord Injury (Stim2Stand)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03536338
Recruitment Status : Terminated (COVID-19 pandemic)
First Posted : May 24, 2018
Last Update Posted : June 2, 2020
The Neurokinex Charitable Trust
Inspire Foundation
Royal National Orthopaedic Hospital NHS Trust
Information provided by (Responsible Party):
University College, London

Brief 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: Spinal Stimulation Other: Sit-to-stand Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Purposefully sampled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spinal Stimulation Sit-to-Stand Training After Spinal Cord Injury
Actual Study Start Date : July 24, 2018
Actual Primary Completion Date : March 23, 2020
Actual Study Completion Date : March 23, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Control
Sit-to-stand training alone
Other: Sit-to-stand Training
Rehabilitation of standing from a chair using the Keiser Rack

Experimental: Treatment
Sit-to-stand training combined with Spinal Stimulation
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

Primary Outcome Measures :
  1. Lower limb motor control (Electromyography) [ Time Frame: Two hours ]
    Muscle activity and voluntary movement in the lower limbs

Secondary Outcome Measures :
  1. Sit-to-stand performance [ Time Frame: 30 mins ]
    Muscle activity and movement when standing from a chair

  2. Health-related quality of life (QoL) [ Time Frame: 1 hour ]

  3. Bladder function (Urodynamics) [ Time Frame: 2 hours ]
    Measuring bladder pressure during bladder filling

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Spinal Cord Injury for >1 year
  • SCI level C5 -- T12
  • Aged >18 years
  • AIS A-D
  • Unable to stand from a chair unaided

Exclusion Criteria:

  • Cardiac pacemaker
  • Any other musculoskeletal diagnosis affecting the lower limbs
  • Pregnancy
  • Complex regional pain syndrome
  • Implanted metal or active device at electrode site (caudle to T9; e.g. screws, contraceptive coil)
  • Spinal malignancy
  • Uncontrolled autonomic dysreflexia
  • Neurological degenerative diseases
  • Peripheral nerve damage affecting the lower limbs
  • Currently on any form of anti-spasticity treatment (e.g. Botox)
  • Osteoporotic - bone density T score less than-2.5 (critical value).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536338

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United Kingdom
Royal National Orthopaedic Hospital
Stanmore, Middlesex, United Kingdom, HA74LP
Sponsors and Collaborators
University College, London
The Neurokinex Charitable Trust
Inspire Foundation
Royal National Orthopaedic Hospital NHS Trust
Additional Information:
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03536338    
Other Study ID Numbers: 17/0625
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College, London:
Sit-to-stand; Spinal Stimulation; transcutaneous
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System