Spinal Cord InjuriesNCT04265560
Progressive Resistance Training in Acute Spinal Cord Injury
A study testing Progressive Resistance Training in people with Spinal Cord Injuries and Quadriplegia, run by Glasgow Caledonian University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Quadriplegia, Trauma, Nervous System
- What is being tested?
- Progressive Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2019to 27 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Progressive Resistance Training in Acute Spinal Cord Injury: a Pilot Randomised Controlled Trial
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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Quadriplegia, Trauma, Nervous System, Paralysis, Spinal Cord Diseases
- Being tested
- Progressive Resistance Training
- Keywords
- Spinal Cord Injury, Progressive Resistance Training, Physical Therapy, Physiotherapy, Strength Training
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia, Trauma, Nervous System, Paralysis, Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Resistance TrainingOther
Progressive resistance training programme for individuals following spinal cord injury.
| Study group | Role | What they receive |
|---|---|---|
| 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)). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 8 weeks
Secondary outcomes (4)
Manual muscle testing
Muscular strength will be quantified using manual muscle testing, 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. Manual muscle testing using the Medical Research Council ordinal scale will be conducted once using standardised positions. This scale ranges from 0 to 5, 0: no palpable or visible muscle contraction, up to 5: muscle can move against gravity and maximal resistance over full range of motion.
Measured: Baseline, 8 weeks
The Spinal Cord Independence Measure (SCIM III)
The Spinal Cord Independence Measure (SCIM III) is a measure of functional independence for individuals with SCI. It is composed of 19 items that assesses 3 domains: self-care, respiration and sphincter management and mobility. The total SCIM III scores range from 0 to 100. 0 represents total dependence, 100 represents complete independence. The blind assessor will score participants on the items for each subscale. The subscale 'self-care' exclusively relates to upper limb ability. SCIM III reflects important aspects of independence specific to the SCI population. Its use has been recommended for individuals with tetraplegia, changes within the self-care category relate to changes in upper limb function. Furthermore, it has been reported to be reliable and valid for patients with traumatic SCI.
Measured: Baseline, 8 weeks
The Action Research Arm Test (ARAT)
Upper limb function will be assessed using The Action Research Arm Test (ARAT) following the standardised protocol outlined by Yozbatiran et al., (2008). The ARAT assesses participants ability to grasp, grip and pinch objects, and make gross motor movements. Standardised materials are required including a box with wooden blocks, alloy tubes, cups, marbles etc. Score for the ARAT ranges from 0-57 points, 57 points represents the best possible performance.
Measured: Baseline, 8 weeks
Perception of ability
At the end of the intervention period, each participant in the intervention group will be asked to rate if their functional goal has changed on a 15-point scale from -7 'a very great deal worse', to +7 'a very great deal better'.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Nov 2019
- Primary completion27 Mar 2020
- Study completion27 Mar 2020
Why it stopped: Restrictions due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hannah Houliston, Principal investigator, Glasgow Caledonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265560
- Sponsor's protocol ID
- 19/WS/0149
- Status last verified
- Mar 2021
- First submitted
- 29 Jan 2020
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressive Resistance Training in Acute Spinal Cord Injury: a Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04265560
- Acronym / sponsor ID
- 19/WS/0149
- Conditions
- Spinal Cord Injuries, Quadriplegia, Trauma, Nervous System, Paralysis, Spinal Cord Diseases
- Keywords
- Spinal Cord Injury, Progressive Resistance Training, Physical Therapy, Physiotherapy, Strength Training
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Restrictions due to COVID-19
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 27 Mar 2020 (actual)
- Study completion
- 27 Mar 2020 (actual)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive Resistance Training | Experimental | Other: Progressive Resistance TrainingThe 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)). |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Resistance TrainingProgressive resistance training programme for individuals following spinal cord injury. | Other | Progressive Resistance Training |
Primary outcome
Change in muscular strength - handheld dynamometry
Time frame: Baseline, 8 weeks
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.
4 secondary outcomes
Manual muscle testing
Time frame: Baseline, 8 weeks
The Spinal Cord Independence Measure (SCIM III)
Time frame: Baseline, 8 weeks
The Action Research Arm Test (ARAT)
Time frame: Baseline, 8 weeks
Perception of ability
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Restrictions due to COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah Houliston principal investigator
Glasgow Caledonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Resistance Training in people with Spinal Cord Injuries and Quadriplegia, run by Glasgow Caledonian University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Restrictions due to COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscular strength - handheld dynamometry (time frame: Baseline, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.