Progressive Resistance Training in Acute Spinal Cord Injury

NCT04265560 | Terminated

• 1 other identifier: 19/WS/0149
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Spinal Cord Injury; Progressive Resistance Training; Physical Therapy; Physiotherapy; Strength Training

Outcome Measures

Primary Outcomes (1)

• Change in muscular strength - handheld dynamometry

  Muscular strength will be quantified using handheld dynamometry, the main upper limb muscle groups will be assessed, bilaterally. Shoulder flexors, extensors, abductors, adductors, lateral rotators, and medial rotators, elbow flexors and extensors, forearm pronators and supinators, and wrist flexors and extensors will be assessed. The order of testing the muscle groups will be consistent. Handheld dynamometry will be conducted implementing the 'make' test. The participant will exert a maximal force against the device whilst the assessor will maintain the position of the device. Three trials will be performed for each upper limb muscle group. Prevention of muscle fatigue will be achieved by a 30-second recovery after each trial and 2 minutes rest between muscle groups. One or 2 trials will be used to familiarise participants with the testing procedure.

  Baseline, 8 weeks

Secondary Outcomes (4)

• Manual muscle testing

  Baseline, 8 weeks

• The Spinal Cord Independence Measure (SCIM III)

  Baseline, 8 weeks

• The Action Research Arm Test (ARAT)

  Baseline, 8 weeks

• Perception of ability

  8 weeks

Study Arms (2)

Progressive Resistance Training

EXPERIMENTAL

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)).

Other: Progressive Resistance Training

Usual care only

NO INTERVENTION

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.

Interventions

Progressive Resistance Training OTHER

Progressive resistance training programme for individuals following spinal cord injury.

Progressive Resistance Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Glasgow Caledonian University: lead

Study Sites (1)

Queen Elizabeth University Hospital

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hannah Houliston

  Glasgow Caledonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: February 11, 2020
• Study Start: November 1, 2019
• Primary Completion: March 27, 2020
• Study Completion: March 27, 2020
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)