Clinical trial NCT04265560: Progressive Resistance Training in Acute Spinal Cord Injury
Official title: Progressive Resistance Training in Acute Spinal Cord Injury: a Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Injuries
Quadriplegia
Trauma, Nervous System
Paralysis
Spinal Cord Diseases
Keywords: Spinal Cord Injury
Progressive Resistance Training
Physical Therapy
Physiotherapy
Strength Training
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in muscular strength - handheld dynamometry
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Manual muscle testing
timeFrame: Baseline, 8 weeks
measure: The Spinal Cord Independence Measure (SCIM III)
timeFrame: Baseline, 8 weeks
measure: The Action Research Arm Test (ARAT)
timeFrame: Baseline, 8 weeks
measure: Perception of ability
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
Study officials:
affiliation: Glasgow Caledonian University
name: Hannah Houliston
role: PRINCIPAL_INVESTIGATOR
References: