Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-03-04 @ 10:24 PM
Study NCT ID:
NCT04265560
Status:
TERMINATED
Last Update Posted:
2021-03-10
First Post:
2020-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Progressive Resistance Training in Acute Spinal Cord Injury
Sponsor:
Glasgow Caledonian University
Organization:
Study Overview
Official Title:
Progressive Resistance Training in Acute Spinal Cord Injury: a Pilot Randomised Controlled Trial
Status:
TERMINATED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Restrictions due to COVID-19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: