Incomplete spinal cord injury Nervous System Diseases
Conditions
Interventions
A minimisation randomisation method (Altman and Bland, 2005) will be used to ensure balance of covariates, including sex, age, types of injury, levels of injury, and motor scores of the AIS below the
thus the study is a single-blinded randomised controlled trial.
The intervention will start after the randomisation. Both the ACET and control groups will continue the standard of care in-patient reh
the study intervention does not interfere with the standard care.
Participants in the ACET group will undertake an arm-crank exercise training programme consisting of 3 x 30 minutes per week for week
4 x 30 minutes/week for weeks 3-4
5 x 30 minutes/week for weeks 5-8 in an upright seated posture. This progressive training protocol was suggested by PPI participants to be more acceptable by patients at early stages of SCI. Exercise
this information will be used to evaluate compliance and adherence to the intervention protocol.
Participants in the control group will not receive additional treatment.
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Updated inclusion criteria as of 18/07/2025: 1. Aged 18 years and above 2. Post-injury < 6 months 3. Cervical or thoracic incomplete SCI 4. Able to sit without support for 30 seconds 5. Sufficient upper-limb function to voluntarily perform arm cycling movement on a stationary arm bike, with or without use of gripping aids Previous inclusion criteria: 1. Are aged 18 years and above 2. Have a cervical or upper thoracic sensory incomplete spinal cord injury 3. Have had the injury within 6 months 4. Are able to sit with support/independently for 30 seconds 5. Have the ability to voluntarily move the elbow to operate the arm bike, bandage or active grip can be used to help holding the pedals
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 18/07/2025: 1. Ongoing issues with shoulder instability or shoulder pain 2. Contraindications to exercise in an upright posture (e.g., postural hypotension, unresolved pressure ulcer, uncontrolled cardiovascular conditions) 3. Pregnancy 4. Unable to understand explanation of the study and/or instructions of the intervention Previous exclusion criteria: 1. Have ongoing issues with shoulder instability or shoulder pain 2. Are unable to use the bike due to lack of muscle activity to activate the bike (e.g., AIS B or C at cervical level). This will assess case-by-case and discussion with the medical care team will be in place prior to study participation. 3. Have contraindications to exercise in an upright posture (e.g., postural hypotension, ulcers). 4. Are pregnant. 5. Are not able to understand what is involved in the study or who cannot understand written or verbal English will not be recruited given the scale of the study being a pilot study and the exercise is self-initiated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 17/07/2025: 1. Trunk control neurophysiological mechanisms measured by surface electromyography (EMG), and spinal excitability below the level of injury, assessed by eliciting motor evoked potentials of the spinal cord using electrical stimulation 2. Dynamic sitting balance assessed using functional reach tasks. Participants will be instructed to reach in multiple directions with one arm as far as they can without losing balance. One inertial measurement unit (IMU) and surface EMG will be placed over the upper part of the back, and a video recording will be used to capture angular displacement and trunk muscle activity during the tasks. Assessment will be conducted at the spinal units of the collaborating NHS Trusts. Two repeated baseline assessments (T0 and T1) will be performed prior to the start of the ACET to allow for the estimation of spontaneous recovery. A post-assessment will be performed at the completion of the ACET (T2), followed by a follow-up assessment at 6 months after the post-assessment (T3). A 6-month follow-up will allow the researchers to evaluate any long-term changes in physical and psychological function as a result of ACET. The same assessment time points will be applied to the control group. _____ Previous primary outcome measure as of 12/08/2024: 1. Muscle activity of the key muscles during maximal and submaximal voluntary contractions, measured by surface electromyography (EMG) 2. Dynamic sitting balance assessed using functional reach tasks. Participants will be instructed to reach in multiple directions with one arm as far as they can without losing balance. Two inertial measurement units (IMUs) and surface EMG will be placed over the upper and lower parts of the back to record angular displacement and muscle activity of the trunk, respectively, during the tasks. Assessment will be conducted at the spinal units of the collaborating NHS Trusts. Two repeated baseline assessments (T0 and T1) wil | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 17/07/2025: 1. Adherence to the intervention: exercise duration, intensity, and frequency documented in the exercise diary will be analysed to evaluate participants’ adherence to the ACET. 2. Motor impairment measured using the American Spinal Injury Association Impairment Scale (AIS) motor scores below the level of injury 3. Self-care, respiration, sphincter management, and mobility assessed using the Spinal Cord Independence Measure (SCIM-3) questionnaire 4. Pain, psychological wellbeing and health-related quality of life assessed via questionnaires: the DN4 questionnaire, the Patient Health Questionnaire-9, Generalised Anxiety Disorder Assessment (GAD-7), Short Form-36 (SF-36) 5. Motivation to engage in the ACET and self-efficacy regarding confidence to perform the arm-crank exercise at the duration and intensity recommended over the course of the programme, assessed using a self-efficacy and motivation questionnaire. 6. Physical activity will be measured with the Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI). This outcome was approved in our most recent ethics amendment. 7. Recording physical activity with a wrist-worn accelerometer for 7 days before and 7 days after the intervention. Assessment will be conducted at the spinal units of the collaborating NHS Trusts. Two repeated baseline assessments (T0 and T1) will be performed prior to the start of the ACET to allow for the estimation of spontaneous recovery. A post-assessment will be performed at the completion of the ACET (T2), followed by a follow-up assessment at 6 months after the post-assessment (T3). A 6-month follow-up will allow the researchers to evaluate any long-term changes in physical and psychological function as a result of ACET. The same assessment time points will be applied to the control group. Qualitative outcome: A subset of approximately 15 participants will be invited to attend a focus group to dis | — |
Countries
England, United Kingdom
Contacts
Public ContactRocio;Joshua Hidalgo Mas;Kearney
;
Outcome results
None listed