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

NCT03536338 | Terminated

• 1 other identifier: 17/0625
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Sit-to-stand; Spinal Stimulation; transcutaneous

Outcome Measures

Primary Outcomes (1)

• Lower limb motor control (Electromyography)

  Muscle activity and voluntary movement in the lower limbs

  Two hours

Secondary Outcomes (3)

• Sit-to-stand performance

  30 mins

• Health-related quality of life (QoL)

  1 hour

• Bladder function (Urodynamics)

  2 hours

Study Arms (2)

Control

ACTIVE COMPARATOR

Sit-to-stand training alone

Other: Sit-to-stand Training

Treatment

EXPERIMENTAL

Sit-to-stand training combined with Spinal Stimulation

Other: Spinal Stimulation; Other: Sit-to-stand Training

Interventions

Spinal Stimulation OTHER

transcutaneous electrical stimulation of the lumbar spinal cord during rehabilitation.

Treatment

Sit-to-stand Training OTHER

Rehabilitation of standing from a chair using the Keiser Rack

Control; Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University College, London: lead
• The Neurokinex Charitable Trust: collaborator
• Inspire Foundation: collaborator
• Royal National Orthopaedic Hospital NHS Trust: collaborator

Study Sites (1)

Royal National Orthopaedic Hospital

Stanmore, Middlesex, HA74LP, United Kingdom

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Purposefully sampled trial

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: May 24, 2018
• Study Start: July 24, 2018
• Primary Completion: March 23, 2020
• Study Completion: March 23, 2020
• Last Updated: June 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)