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Progressive Resistance Training in Acute Spinal Cord Injury

G

Glasgow Caledonian University

Status

Terminated

Conditions

Spinal Cord Injuries
Trauma, Nervous System
Quadriplegia
Spinal Cord Diseases
Paralysis

Treatments

Other: Progressive Resistance Training

Study type

Interventional

Funder types

Other

Identifiers

NCT04265560
19/WS/0149

Details and patient eligibility

About

Muscle weakness is one of the most common and debilitating symptoms following a Spinal Cord Injury (SCI). Strength training is recommended as an effective means to increase muscular strength and improve function for individuals with long term SCI. In contrast, the strength training guidance for those with a recent (<1 year) SCI is lacking. Therefore, this study aims to investigate the feasibility of a method of upper limb strengthening - Progressive Resistance Training (PRT) and its impact upon muscle strength and function.

Full description

The trial and recruitment will be conducted at the Queen Elizabeth National Spinal Injuries Unit (QENSIU), Glasgow. Individuals with tetraplegia and upper limb weakness will be randomly allocated to receive either a tailored progressive resistance training (PRT) programme alongside usual care or usual care alone.

Up to 30 participants admitted to the QENSIU will be recruited to the study. They will be randomised to the intervention or control group. The intervention group will receive 8 weeks of PRT. An upper limb functional goal will be identified through discussion with the researcher and the participant. PRT will be individually tailored to target two muscle groups which contribute to achieving this goal. For each muscle group 3 sets of 8-10 repetitions will be carried out, resistance will be applied using wrist weights, free weights or resistance bands as required. Measurements of muscle strength and function will be assessed prior to, and following the study. Outcome measures: Manual muscle testing, Handheld Dynamometry, The Spinal Cord Independence Measure, The Action Research Arm Test.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Acquired non-progressive SCI - traumatic, spinal cord stroke, surgical injury
  • Within 2 weeks of being identified as medically stable by the treating consultant
  • Over 18 years old
  • Individuals classified with complete or incomplete tetraplegia (C1-C8), graded A-D according to the American Spinal Injury Association (ASIA) scale
  • Bilateral or unilateral partial paresis of at least two muscle groups of the upper limb
  • Manual muscle testing grade 2-4 strength in target muscle groups
  • Able to tolerate sitting upright in a wheelchair for at least 2 hours

Exclusion criteria

  • Acute condition impairing a participant's ability to perform PRT (e.g. fracture)
  • Proven or suspected neuromuscular weakness affecting the upper limbs due to another condition (e.g. stroke or Guillain-Barré syndrome)
  • Unable to follow instructions in English
  • Symptomatic cardiac disease
  • Ventilator dependency
  • Severe spasticity
  • Uncontrolled autonomic dysreflexia
  • Likely to be discharged before the end of the intervention

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

7 participants in 2 patient groups

Progressive Resistance Training
Experimental group
Description:
The intervention group will receive 8 weeks of Progressive Resistance Training (PRT), twice a week, in addition to usual care. An upper limb functional goal will be identified through discussion with the researcher and the participant. PRT will be individually tailored to target two muscle groups and will be chosen in order to develop strength to progress towards the participants functional goal. The chronic spinal cord injury exercise guideline parameters will be applied (3 sets of 8-10 repetitions, 1-2 mins rest between sets). Participants will be inducted to their PRT programme and will then independently complete the 8 week programme. During each of the following sessions, assistance for set up of equipment and/or limb position will be given by the researcher and/or the participants family, friend or carer, once they have been trained. PRT sessions will be recorded in a diary to monitor sets and repetitions completed, and intensity (visual analogue scale (VAS)).
Treatment:
Other: Progressive Resistance Training
Usual care only
No Intervention group
Description:
Participants will continue with their usual care, consistent with standard National Health Service (NHS) care in this population. Usual physiotherapy care is provided, up to 2 times per day, 4 to 5 days per week, each lasting up to 90 minutes. Physiotherapists provide a combination of group exercise and one to one function-orientated physiotherapy sessions to improve balance, general muscle strength, wheelchair and/or transfer skills.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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