Spinal Stimulation Sit-to-Stand Training After Spinal Cord Injury
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University College, London
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Lower limb motor control (Electromyography)
Study Overview
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.
Detailed Description
Recruitment and Initial Assessment:
Participants will be recruited from London Spinal Cord injuries Centre (LSCIC) at the Royal National Orthopaedic Hospital (RNOH) and Neurokinex neurological rehabilitation centres where the 8-week (24-session) training intervention will be carried out. The study will also be advertised via relevant newsletters, bulletin boards, websites and mailing lists.
First Appointment (Visit 1 - 1 session at RNOH):
Each participant will attend an initial session at the RNOH in Stanmore, lasting one to two hours. Participants will be given the opportunity to ask questions about the study and informed consent to participate in the study will be taken.
Following this, we will perform some simple tests to check muscle response to stimulation without undue discomfort. Stimulating electrodes will be placed over the lower back and recording electrodes will be placed on lower limb muscles. The BCMA will then be completed: participants will be placed in the supine position and asked to perform a number of motor tasks in response to verbal cues (e.g. bring knee to chest). Stimulation will then be delivered in varying patterns (e.g. pulse width and frequency) and intensities (0mA to 100mA) and responses will be recorded from lower limb muscles. From this, optimal electrode position, and threshold level to stimulation will be defined. Trains of stimulation will then be applied at a range of frequencies (1-100Hz) and intensities 0mA to 100mA (or the highest intensity tolerated by the participant, whichever is lower). This will provide information on the pre-intervention ability of the participant. At the end of this session we will arrange with the participant a date for the next baseline session at the Neurokinex location most convenient for the participant to travel too.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Spinal Cord Injury for >1 year
- •SCI level C5 -- T12
- •Aged >18 years
- •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).
Arms & Interventions
Control
Sit-to-stand training alone
Intervention: Sit-to-stand Training (Other)
Treatment
Sit-to-stand training combined with Spinal Stimulation
Intervention: Spinal Stimulation (Other)
Treatment
Sit-to-stand training combined with Spinal Stimulation
Intervention: Sit-to-stand Training (Other)
Outcomes
Primary Outcomes
Lower limb motor control (Electromyography)
Time Frame: Two hours
Muscle activity and voluntary movement in the lower limbs
Secondary Outcomes
- Sit-to-stand performance(30 mins)
- Bladder function (Urodynamics)(2 hours)
- Health-related quality of life (QoL)(1 hour)