Incomplete Spinal Cord Injury
Conditions
Keywords
incomplete spinal cord injury, repetitive transcranial magnetic stimulation, functional electrical stimulation cycling, lower extremity function, walking speed, muscle strength, feasibility
Brief summary
This project is randomized controlled trial which will explore the effect of pairing repetitive Transcranial Magnetic Stimulation (rTMS) with Functional Electrical Stimulation (FES) Cycling on lower extremity function in people with incomplete spinal cord injury and compare the effects to each one of these interventions alone.
Detailed description
Following a spinal cord injury, people often have decreased strength and balance in their legs, making it difficult to walk. To improve leg function in people with spinal cold injuries, the investigators can use electrical stimulation on muscles while participants are cycling to increase the muscle activation and nerve connections. Another way to improve the nerve connections to the muscles is by stimulating the brain directly. Previous research has looked at the effects of each of these treatments, but they have not been used together. In this study, the investigators will pair both electrical stimulation on the legs during cycling with brain stimulation or a sham brain stimulation to improve recovery and determine if using these methods together results in better outcomes, such as increased walking speed. Participants will attend training sessions for six weeks, twice per week. Each person will first receive the active or sham brain stimulation at the beginning of the session for 30 minutes and then they will receive the electrical stimulation on their legs while cycling for 60 minutes. Participants will be evaluated before the start of the treatment, in the middle of the study, at the final session, and again two weeks after the last session of the treatment. Assessments will include clinical tests of gait, balance, and strength. Inertial Measurement Units (IMU) and a pressure sensor gait mat will be used to evaluate the gait and balance parameters.
Interventions
DEVICErepetitive transcranial magnetic stimulation (rTMS)
rTMS will be applied to primary motor cortex of the brain.
DEVICEfunctional electrical stimulation (FES) cycling
FES will be applied to muscles associated in cycling: quadriceps, hamstrings, tibialis anterior, gastrocnemius, soleus.
Sponsors
Western University, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Participants are blinded to their groups. Research assistant and physiotherapist who are responsible for conducting assessment sessions are also blinded to participants group. All the participants will be randomized to groups using opaque envelopes blocked by four and stratified by AIS score.
Intervention model description
This protocol involves two groups of participants: intervention group and control group. Intervention group will receive real rTMS and FES cycling and control group will receive sham rTMS and FES cycling. The results of these groups are then evaluated at several stages of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult * having motor incomplete SCI with level C or D on the American Spinal Injury Association Impairment Scale (AIS) with the lesion at any level of the cord resulting from either traumatic or non-traumatic etiology who are at least one-year post-injury. * having non-progressive SCI * being able to walk independently for 10 meters without help from another person
Exclusion criteria
* other orthopedic or neurological implications that affect the lower extremity function * contraindications to FES (e.g., implanted electronic devices, unhealed bone fractures, sever contractures, extreme osteoporosis or osteoarthritis) * contraindications to rTMS (e.g., metal implants, history of seizure, cochlear implants)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events | 8 weeks | This outcome will be evaluated through descriptive data. Safety will be presented as any adverse reaction reported on verbal questioning at each session. The number of participants reporting adverse reactions, and the duration and severity of the adverse reactions will be reported. |
| Time taken to complete the recruitment of 12 participants | 8 weeks | This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the feasibility of the protocol. |
| Proportion of participants recruited from the total number screened | 8 weeks | This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the feasibility of the protocol. |
| Number of sessions attended by each participant | 8 weeks | This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the tolerability of the protocol. |
| Number of dropouts in each group | 8 weeks | This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the tolerability of the protocol. |
| Willingness of participants to undergo therapy | 8 weeks | This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the tolerability of the protocol. The willingness of participation will be collected on an 11-point numerical rating scale with 'not at all willing' at 0, and 'very willing' at 10 (measured at baseline). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sit-to-stand test | 8 weeks | This instrumental outcome will be collected using Inertial Measurement Units (IMUs). |
| Postural sway test | 8 weeks | This instrumental outcome will be collected using Inertial Measurement Units (IMUs). |
| Walking Index for Spinal Cord Injury (WISCI) II scale | 8 weeks | A blinded physiotherapist will be hired to collect this clinical outcome. Walking Index for Spinal Cord Injury version II scale is rated from 0 to 20 with the higher scores showing better results. |
| Lower Extremity Motor Score (LEMS) | 8 weeks | A blinded physiotherapist will be hired to collect this clinical outcome. Lower Extremity Motor Score is rated from 0 to 5\* as follows: 0= Total paralysis 1. Palpable or visible contraction 2. Active movement, full range of motion (ROM) when gravity is eliminated 3. Active movement, full ROM against gravity 4. Active movement, full ROM against gravity, and moderate resistance in muscle-specific position 5. (Normal) Active movement, full ROM against gravity, and full resistance in a muscle-specific position expected from a healthy person 5\*= (Normal) Active movement, full ROM against gravity, and sufficient resistance to be considered normal if identified inhibiting factors (i.e., pain, disuse) were not present NT = Not testable (i.e., due to immobilization, sever pain that can prevent the grading of the patient, amputation of the limb, or contracture of \>50% of the range of motion) Higher scores in this outcome mean better result. |
| Walking speed | 8 weeks | This instrumental outcome is collected using a pressure sensor gait mat. |
| Step length | 8 weeks | This instrumental outcome is collected using a pressure sensor gait mat. |
| Step width | 8 weeks | This instrumental outcome is collected using a pressure sensor gait mat. |
| Cadence | 8 weeks | This instrumental outcome is collected using a pressure sensor gait mat. |
| Timed Up and Go (TUG) test | 8 weeks | This instrumental outcome will be collected using Inertial Measurement Units (IMUs). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Global Rating of Change (GRC) scale | 8 weeks | Evaluation of the participants' impact will be collected through a GRC questionnaire in each assessment session. Global Rating Scale will ask participants to rate their walking abilities and overall recovery of the lower limb function from the time that they began the treatment until now. This scale is rated from -7 to 7 as follows: * 7: A very great deal worse * 6: A great deal worse * 5: Quite a bit worse * 4: Moderately worse * 3: Somewhat worse * 2: A little bit worse * 1: A tiny bit worse (almost the same) 0: About the same * 1: A tiny bit better (almost the same) * 2: A little bit better * 3: Somewhat better * 4: Moderately better * 5: Quite a bit better * 6: A great deal better * 7: A very great deal better Higher scores in this outcome mean better results. |
Countries
Canada
Contacts
Primary ContactJanelle Unger, PhD
Backup ContactSiobhan Schabrun, BSc
Outcome results
None listed