Spinal Cord Injury CervicalNCT04523636
Evaluation of Splinting in Tetraplegia
A study testing Splinting in people with Spinal Cord Injury Cervical and Splints, run by Thomas Jefferson University at 2 sites in United States.
Trial summary
This study compared pre-fabricated and custom resting hand splints among people who were in inpatient rehabilitation after a cervical spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury Cervical, Splints
- What is being tested?
- Splinting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Jan 2018to 20 Dec 2018
- 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
- Spinal Cord Injury
- Inpatient Rehabilitation
- Limited hand function
Who cannot join
- Under 18
- Full hand function
- Orthopedic injury to hand
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of MD Rehabilitation & Orthopaedic Institute
Baltimore, Maryland, 21207
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
This study compared pre-fabricated and custom resting hand splints among people who were in inpatient rehabilitation after a cervical spinal cord injury.
Read the detailed description
This was randomized parallel group controlled clinical trial where arms, not patients were the unit of randomization. This trial was funded by the Craig H. Neilsen Allied Health Professional Development Award of the American Spinal Injury Association (ASIA). This research was conducted at a 32-bed spinal cord injury and multi-trauma rehabilitation unit in an urban center. Participants were recruited from an inpatient spinal cord injury rehabilitation unit. Eligible participants were 18 years or older and undergoing acute rehabilitation after a cervical spinal cord injury with hand function impairment, and the primary occupational therapist deemed splinting intervention was required. Each eligible extremity was randomized to receive a custom or pre-fabricated resting hand splint for night use.
- Conditions
- Spinal Cord Injury Cervical, Splints
- Being tested
- Splinting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SplintingDevice
Pre-fabricated or custom resting hand splints
| Study group | Role | What they receive |
|---|---|---|
| Custom Splint | Active comparator | Custom Splint- Thermoplastic device fabricated by occupational therapist Receives: Device: Splinting |
| Prefabricated Splint | Active comparator | Prefabricated Splint- Commercially available from Restorative Care of America, Inc (RCAI) Receives: Device: Splinting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scores on The Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP).
This test is a hand function assessment for spinal cord injury consisting of four domains- upper extremity strength, sensation, qualitative prehension, and quantitative prehension. Total scores for each upper extremity are calculated 0-116. Assessment of the Hand in Tetraplegia Using the Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP): Impairment versus Function.
Kalsi-Ryan S, Curt A, Fehlings, MG and Verrier MC. Top Spinal Cord Inj Rehabil (2009); 14(4):34-46. - C
Measured: This assessment is completed within 5 days of initating the splinting intervention and within 3 days of discharge. Length of time between data collection was limited to 12 weeks.
Secondary outcomes (1)
Splint Perception Survey
This survey gathered participant perceptions via a 5 point Likert scale on the participant's perceptions of the splint's comfort and impact on function and hand position. Additionally, participants were asked to provide their perceptions on challenges to using the splint and advice to future therapists and patients considering splinting.
Measured: This assessment was completed within 3 days of discharge and no more than 12 weeks after the intervention was initiated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start4 Jan 2018
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury CervicalStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- 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
- Model description
- Each extremity was randomized to receive a custom or pre-fabricated resting hand splint.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, Baltimore, The Craig H. Neilsen Foundation
- Responsible party
- Sponsor
- Investigators
- Peter Gorman, MD, Principal investigator, University of Maryland, BaltimorePaula Geigle, PhD, Principal investigator, University of Maryland, BaltimoreSara Frye, MS, Study director, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523636
- Sponsor's protocol ID
- HP-00075158
- Status last verified
- Aug 2020
- First submitted
- 18 Aug 2020
- Last updated
- 21 Aug 2020
- 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 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Splinting in Tetraplegia
- ClinicalTrials.gov ID
- NCT04523636
- Acronym / sponsor ID
- HP-00075158
- Conditions
- Spinal Cord Injury Cervical, Splints
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- University of Maryland, Baltimore, The Craig H. Neilsen Foundation
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 21 Aug 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.
This study compared pre-fabricated and custom resting hand splints among people who were in inpatient rehabilitation after a cervical spinal cord injury.
Detailed description
This was randomized parallel group controlled clinical trial where arms, not patients were the unit of randomization. This trial was funded by the Craig H. Neilsen Allied Health Professional Development Award of the American Spinal Injury Association (ASIA). This research was conducted at a 32-bed spinal cord injury and multi-trauma rehabilitation unit in an urban center. Participants were recruited from an inpatient spinal cord injury rehabilitation unit. Eligible participants were 18 years or older and undergoing acute rehabilitation after a cervical spinal cord injury with hand function impairment, and the primary occupational therapist deemed splinting intervention was required. Each eligible extremity was randomized to receive a custom or pre-fabricated resting hand splint for night use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each extremity was randomized to receive a custom or pre-fabricated resting hand splint.
| Arm | Type | Receives |
|---|---|---|
| Custom Splint | Active comparator | Device: SplintingCustom Splint- Thermoplastic device fabricated by occupational therapist |
| Prefabricated Splint | Active comparator | Device: SplintingPrefabricated Splint- Commercially available from Restorative Care of America, Inc (RCAI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Spinal Cord Injury
- Inpatient Rehabilitation
- Limited hand function
Key exclusion criteria (3 listed)
- Under 18
- Full hand function
- Orthopedic injury to hand
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 |
|---|---|---|
| SplintingPre-fabricated or custom resting hand splints | Device | Custom Splint, Prefabricated Splint |
Primary outcome
Change in scores on The Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP).
Time frame: This assessment is completed within 5 days of initating the splinting intervention and within 3 days of discharge. Length of time between data collection was limited to 12 weeks.
This test is a hand function assessment for spinal cord injury consisting of four domains- upper extremity strength, sensation, qualitative prehension, and quantitative prehension. Total scores for each upper extremity are calculated 0-116. Assessment of the Hand in Tetraplegia Using the Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP): Impairment versus Function. Kalsi-Ryan S, Curt A, Fehlings, MG and Verrier MC. Top Spinal Cord Inj Rehabil (2009); 14(4):34-46. - C
1 secondary outcome
Splint Perception Survey
Time frame: This assessment was completed within 3 days of discharge and no more than 12 weeks after the intervention was initiated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- 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.
Peter Gorman, MD principal investigator
University of Maryland, Baltimore
Paula Geigle, PhD principal investigator
University of Maryland, Baltimore
Sara Frye, MS study director
Thomas Jefferson University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Splinting in people with Spinal Cord Injury Cervical and Splints, run by Thomas Jefferson University at 2 sites in United States.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 scores on The Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP). (time frame: This assessment is completed within 5 days of initating the splinting intervention and within 3 days of discharge. Length of time between data collection was limited to 12 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 21 Aug 2020.