Early rehabilitation promoting motor recovery from spinal cord injury

Early self-initiated upper-body exercise to improve volitional control below the level of injury after spinal cord injury

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN89333770

Enrollment

Registered

2022-07-19

Start date

2022-08-01

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic and non-traumatic cervical and thoracic spinal cord injury. Nervous System Diseases

Interventions

The intervention will start after the randomisation. Both the arm-crank exercise training (ACET) and control groups will continue the standard of care in-patient rehabilitation

the study intervention does not interfere with the standard care. A minimisation randomisation method (Altman and Bland, 2005) will be used to ensure balance of covariates, including sex, age, types o

this information will be used to evaluate compliance and adherence to the intervention protocol. Participants in the control group will not receive additional treatment. Participants in the control g

Eligibility

Sex/Gender

All

Age

18 Years to 120 Years

Inclusion criteria

Inclusion criteria: 1. Aged =18 years 2. Cervical or upper thoracic sensory incomplete spinal cord injury (American Spinal Injury Association Impairment Scale [AIS] Grade B, C, or D) 3. Had the injury within the past 2 months 4. Able to voluntarily move the elbow to operate the arm bike. Bandage or active grip can be used to help hold the pedals.

Exclusion criteria

Exclusion criteria: 1. Ongoing issues with shoulder instability or shoulder pain 2. Unable to use the bike due to lack of muscle activity to activate the bike (e.g. American Spinal Injury Association Impairment Scale [AIS] Grade B or C at cervical level). This will be assessed on a case-by-case and discussion with the medical care team will be in place prior to study participation. 3. Contraindications to exercise in an upright posture (e.g. postural hypotension, ulcers) 4. Pregnant 5. Unable to understand what is involved in the study or cannot understand written or verbal English

Design outcomes

Primary

Measure	Time frame
1. Muscle activity of the key muscles during maximal voluntary contractions (MVCs) measured by surface electromyography at baseline, 4 weeks, post-intervention, and 3 months after the intervention 2. Motor impairment measured using the American Spinal Injury Association Impairment Scale (AIS) motor scores below the level of injury at baseline, 4 weeks, post-intervention, and 3 months after the intervention	—

Measure

Time frame

1. Muscle activity of the key muscles during maximal voluntary contractions (MVCs) measured by surface electromyography at baseline, 4 weeks, post-intervention, and 3 months after the intervention 2. Motor impairment measured using the American Spinal Injury Association Impairment Scale (AIS) motor scores below the level of injury at baseline, 4 weeks, post-intervention, and 3 months after the intervention

—

Secondary

Measure	Time frame
1. Adherence to the intervention measured as exercise duration, intensity, and frequency recorded by the fitness watches throughout the intervention 2. Sitting balance measured using two inertial measurement units (IMUs) placed over the upper and lower parts of the back to record postural sway during a stability test at baseline, 4 weeks, post-intervention, and 3 months after the intervention. In this test participants will be asked to maintain upright seated position in a standardised chair without a back support for 10 s and will also be asked to raise bilateral arms in response to a visual cue while maintaining their stability. 3. Dynamic sitting balance measured using two IMUs placed over the upper and lower parts of the back to record angular displacement of the trunk during functional reach tasks at baseline, 4 weeks, post-intervention, and 3 months after the intervention. In these tasks participants will be instructed to reach in multiple directions (forward, right side, and left side) with one arm as far as they can without losing balance (Field-Fote and Ray, 2010). 4. Spinal excitability below the level of injury measured using surface electrodes placed over muscle bellies of the triceps surae bilaterally and a stimulator probe placed at the popliteal fossa to stimulate the tibial nerves to induce maximal motor response (M-waves) and Hoffmann (H-) reflexes using electrical stimulation (Chiou et al., 2017) while participants are in supine lying position at baseline, 4 weeks, post-intervention, and 3 months after the intervention 5. Spasticity in the knee extensors and ankle plantar flexor measured using the Modified Ashworth Scale (MAS) at baseline, 4 weeks, post-intervention, and 3 months after the intervention 6. Self-care, respiration, sphincter management, and mobility measured using the Spinal Cord Independence Measure (SCIM-3) questionnaire at baseline, 4 weeks, post-intervention, and 3 months after the intervention 7. Pain, psychological wellbeing a	—

Measure

Time frame

1. Adherence to the intervention measured as exercise duration, intensity, and frequency recorded by the fitness watches throughout the intervention 2. Sitting balance measured using two inertial measurement units (IMUs) placed over the upper and lower parts of the back to record postural sway during a stability test at baseline, 4 weeks, post-intervention, and 3 months after the intervention. In this test participants will be asked to maintain upright seated position in a standardised chair without a back support for 10 s and will also be asked to raise bilateral arms in response to a visual cue while maintaining their stability. 3. Dynamic sitting balance measured using two IMUs placed over the upper and lower parts of the back to record angular displacement of the trunk during functional reach tasks at baseline, 4 weeks, post-intervention, and 3 months after the intervention. In these tasks participants will be instructed to reach in multiple directions (forward, right side, and left side) with one arm as far as they can without losing balance (Field-Fote and Ray, 2010). 4. Spinal excitability below the level of injury measured using surface electrodes placed over muscle bellies of the triceps surae bilaterally and a stimulator probe placed at the popliteal fossa to stimulate the tibial nerves to induce maximal motor response (M-waves) and Hoffmann (H-) reflexes using electrical stimulation (Chiou et al., 2017) while participants are in supine lying position at baseline, 4 weeks, post-intervention, and 3 months after the intervention 5. Spasticity in the knee extensors and ankle plantar flexor measured using the Modified Ashworth Scale (MAS) at baseline, 4 weeks, post-intervention, and 3 months after the intervention 6. Self-care, respiration, sphincter management, and mobility measured using the Spinal Cord Independence Measure (SCIM-3) questionnaire at baseline, 4 weeks, post-intervention, and 3 months after the intervention 7. Pain, psychological wellbeing a

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 25, 2026