Cervical Spinal Cord InjuryNCT05191121
Improving Upper Extremity Function and Trunk Stability After Cervical Spinal Cord Injury (SCI)
A study testing FTP Alone, FTP+Con-FES and FTP+WPHF-FES in people with Cervical Spinal Cord Injury, run by Craig Hospital at 1 site in United States.
Trial summary
Ninety-nine individuals meeting the study's inclusion/exclusion criteria will be enrolled in this study. The objective of this study is to evaluate three different therapeutic approaches to synergistically retrain functional movement patterns of the upper extremities in combination with trunk stabilization to promote… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Spinal Cord Injury
- What is being tested?
- FTP Alone, FTP+Con-FES and FTP+WPHF-FES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2022to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- History of traumatic SCI
- Less than 5months post SCI
- SCI injury level C1-C8
- SCI categorized as AIS B-D
- Currently receiving inpatient rehabilitation at Craig Hospital
- Passive range of motion (ROM) within functional limits at wrists, shoulders, and elbows
Show all 9Show fewer
- Demonstrate motor response to electrical stimulation in majority of UE muscle groups below level of injury (tested during screening)
- No complicating physical or cognitive conditions (as determined by their physician) that would preclude safe use of electrical stimulation
- Able to complete study as an outpatient if discharged from inpatient rehabilitation before completing 40 sessions of training
Who cannot join
- Unstable chronic cardiac or respiratory complaints
- Current or history of UE contracture or skin pressure injuries that might interfere with intervention
- Received Botox injections within the last 3 months
- Pregnant
- Implanted devices including: pacemaker, spinal cord stimulator, ventriculoperitoneal shunt, deep brain stimulator, or intra-thecal pump.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Improving Upper Extremity Function and Trunk Stability After Cervical Spinal Cord Injury (SCI): A Randomized Controlled Trial of Three Interventions
Ninety-nine individuals meeting the study's inclusion/exclusion criteria will be enrolled in this study. The objective of this study is to evaluate three different therapeutic approaches to synergistically retrain functional movement patterns of the upper extremities in combination with trunk stabilization to promote neurologic and functional recovery after SCI. Each subject will complete 40 sessions of intervention. Subjects will also complete a Baseline Evaluation (week 0), Re-Evaluation (week 4), Post Treatment Evaluation (week 8), and a Follow-Up Evaluation (week 12).
- Conditions
- Cervical Spinal Cord Injury
- Being tested
- FTP Alone, FTP+Con-FES, FTP+WPHF-FES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FTP AloneBehavioural
Participants will be challenged with training speed, weight, limited therapist support, and context variation (e.g., fine motor activities will vary using objects such as cards, dice, coins).
FTP+Con-FESBehavioural
Participants will be challenged with training speed, weight, limited therapist support, and context variation (e.g., fine motor activities will vary using objects such as cards, dice, coins). Muscle groups will be stimulated at the same time they would be activated naturally in a pre-injury movement pattern utilizing conventional parameter FES.
FTP+WPHF-FESBehavioural
Participants will be challenged with training speed, weight, limited therapist support, and context variation (e.g., fine motor activities will vary using objects such as cards, dice, coins). Muscle groups will be stimulated at the same time they would be activated naturally in a pre-injury movement pattern utilizing wide pulse, high frequency parameter FES.
| Study group | Role | What they receive |
|---|---|---|
| FTP Alone | Active comparator | Functional Task Practice Alone - Participants allocated to this group will complete 40 minutes of training focused on improving functional tasks followed by 10 minutes of functional training/carryover in a relevant environment without functional electrical stimulation (FES). Receives: Behavioral: FTP Alone |
| FTP+Con-FES | Active comparator | Functional Task Practice + Conventional Functional Electrical Stimulation - Participants allocated to this group will complete 40 minutes of training focused on improving functional tasks supplemented with conventional parameter (200µs; 40Hz) functional electrical stimulation (FES). followed by 10 minutes of functional training/carryover in a relevant environment. Receives: Behavioral: FTP+Con-FES |
| FTP+WPHF-FES | Active comparator | Functional Task Practice + Wide Pulse, High Frequency Functional Electrical Stimulation - Participants allocated to this group will complete 40 minutes of training focused on improving functional tasks supplemented with wide pulse, high frequency (1000µs; 100 Hz) functional electrical stimulation (FES) followed by 10 minutes of functional training/carryover in a relevant environment. Receives: Behavioral: FTP+WPHF-FES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capabilities of Upper Extremity Test (CUE-T)
32 item test, each item scored on a 0-4 point scale with total scores ranging from 0-128.
Measured: Week 0 to Week 12
Secondary outcomes (13)
Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP)
This multimodal test measures sensorimotor and prehension function in three domains important in describing arm and hand function
Measured: Week 0, Week 8, and Week 12
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sensory Level
The ISNCSCI involves a detailed examination to determine the sensory level for the right and left sides. The sensory level is the most caudal, intact dermatome. Scores range from 0-2. The higher the score the more intact the dermatome is.
Measured: Week 0, Week 8, and Week 12
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Level
The ISNCSCI involves a detailed examination to determine motor levels for the right and left sides. The motor level is defined as the lowest key muscle function that has a grade of at least a 3, providing key muscle functions represented by segments above that level are judged to be intact. Scores range from 0-5. The higher the score the more intact the muscle is.
Measured: Week 0, Week 8, and Week 12
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurological Level of Injury
The ISNCSCI involves a detailed examination to determine the neurological level of injury. The neurological level of injury refers to the most caudal segment of the cord with intact sensation and antigravity muscle function strength, provided that there is normal sensory and motor function rostrally respectively. The neurological level of injury is the most cephalad of the sensory and motor levels.
Measured: Week 0, Week 8, and Week 12
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sacral Sparing
The ISNCSCI involves a detailed examination to determine whether a spinal cord injury is complete or incomplete. If an injury is considered complete there is an absence of voluntary anal contraction, absent sensory scores of S4-5, and absence of deep anal pressure.
Measured: Week 0, Week 8, and Week 12
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Impairment Grade
The ISNCSCI involves a detailed examination to determine a spinal cord injury's grade according to the American Spinal Injury Association. Score ranges from A-E. ASIA classification A means spinal injury is considered complete with no sensory or motor function preserved in sacral segments. On the opposite end of the scale an ASIA classification E means 'normal'.
Measured: Week 0, Week 8, and Week 12
Pinch Force
Pinch force will be measured by the Commander Echo Console with the JTech Pinch Dynamometer to quantify finger strength.
Measured: Week 0, Week 8, and Week 12
Grasp Force
Grasp force will be measured by the Commander Echo Console with the JTech Hand Dynamometer to quantify grasp strength.
Measured: Week 0, Week 8, and Week 12
Modified Functional Reach (MFR)
The MFR will be used to measure dynamic trunk stability
Measured: Week 0, Week 8, and Week 12
Global Rating of Change (GRC)
The Global Rating of Change scale assesses perceived change from an intervention. 9 point Likert scale. Higher positive score reflects great improvement
Measured: Week 0, Week 8, and Week 12
NeuroRecovery Scale (NRS)
The full NRS comprises of 16items. For the purpose of this upper extremity interventional study, only six items will be used that represent a variety of functional upper extremity movement patterns required for ADL management. These scores will be used to guide treatment across all 3 groups. Scores range from 1A-4C. Higher scores reflect greater recovery of spinal cord injury.
Measured: Week 0 and Week 4
Demographic Information
Demographic information will include: age, sex, race/ethnic background, pre-injury education, employment status, marital status, and living situation.
Measured: Week 0
Injury Information
Injury information will include: date of injury, cause of injury, baseline AIS classification, and injury level.
Measured: Week 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start23 Feb 2022
- Primary completionFeb 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spinal Cord InjuryStudies 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
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Craig Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Candace Tefertiller, Craig Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191121
- Sponsor's protocol ID
- 1847023-1
- Status last verified
- Mar 2026
- First submitted
- 28 Dec 2021
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Upper Extremity Function and Trunk Stability After Cervical Spinal Cord Injury (SCI): A Randomized Controlled Trial of Three Interventions
- ClinicalTrials.gov ID
- NCT05191121
- Acronym / sponsor ID
- 1847023-1
- Conditions
- Cervical Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Craig HospitalUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 Jan 2022 (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.
Ninety-nine individuals meeting the study's inclusion/exclusion criteria will be enrolled in this study. The objective of this study is to evaluate three different therapeutic approaches to synergistically retrain functional movement patterns of the upper extremities in combination with trunk stabilization to promote neurologic and functional recovery after SCI. Each subject will complete 40 sessions of intervention. Subjects will also complete a Baseline Evaluation (week 0), Re-Evaluation (week 4), Post Treatment Evaluation (week 8), and a Follow-Up Evaluation (week 12).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FTP Alone | Active comparator | Behavioral: FTP AloneFunctional Task Practice Alone - Participants allocated to this group will complete 40 minutes of training focused on improving functional tasks followed by 10 minutes of functional training/carryover in a relevant environment without functional electrical stimulation (FES). |
| FTP+Con-FES | Active comparator | Behavioral: FTP+Con-FESFunctional Task Practice + Conventional Functional Electrical Stimulation - Participants allocated to this group will complete 40 minutes of training focused on improving functional tasks supplemented with conventional parameter (200µs; 40Hz) functional electrical stimulation (FES). followed by 10 minutes of functional training/carryover in a relevant environment. |
| FTP+WPHF-FES | Active comparator | Behavioral: FTP+WPHF-FESFunctional Task Practice + Wide Pulse, High Frequency Functional Electrical Stimulation - Participants allocated to this group will complete 40 minutes of training focused on improving functional tasks supplemented with wide pulse, high frequency (1000µs; 100 Hz) functional electrical stimulation (FES) followed by 10 minutes of functional training/carryover in a relevant environment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- History of traumatic SCI
- Less than 5months post SCI
- SCI injury level C1-C8
- SCI categorized as AIS B-D
- Currently receiving inpatient rehabilitation at Craig Hospital
Key exclusion criteria (5 listed)
- Unstable chronic cardiac or respiratory complaints
- Current or history of UE contracture or skin pressure injuries that might interfere with intervention
- Received Botox injections within the last 3 months
- Pregnant
- Implanted devices including: pacemaker, spinal cord stimulator, ventriculoperitoneal shunt, deep brain stimulator, or intra-thecal pump.
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 |
|---|---|---|
| FTP AloneParticipants will be challenged with training speed, weight, limited therapist support, and context variation (e.g., fine motor activities will vary using objects such as cards, dice, coins). | Behavioural | FTP Alone |
| FTP+Con-FESParticipants will be challenged with training speed, weight, limited therapist support, and context variation (e.g., fine motor activities will vary using objects such as cards, dice, coins). Muscle groups will be stimulated at the same time they would be activated naturally in a pre-injury movement pattern utilizing conventional parameter FES. | Behavioural | FTP+Con-FES |
| FTP+WPHF-FESParticipants will be challenged with training speed, weight, limited therapist support, and context variation (e.g., fine motor activities will vary using objects such as cards, dice, coins). Muscle groups will be stimulated at the same time they would be activated naturally in a pre-injury movement pattern utilizing wide pulse, high frequency parameter FES. | Behavioural | FTP+WPHF-FES |
Primary outcome
Capabilities of Upper Extremity Test (CUE-T)
Time frame: Week 0 to Week 12
32 item test, each item scored on a 0-4 point scale with total scores ranging from 0-128.
13 secondary outcomes
Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP)
Time frame: Week 0, Week 8, and Week 12
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sensory Level
Time frame: Week 0, Week 8, and Week 12
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Level
Time frame: Week 0, Week 8, and Week 12
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurological Level of Injury
Time frame: Week 0, Week 8, and Week 12
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sacral Sparing
Time frame: Week 0, Week 8, and Week 12
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Impairment Grade
Time frame: Week 0, Week 8, and Week 12
Pinch Force
Time frame: Week 0, Week 8, and Week 12
Grasp Force
Time frame: Week 0, Week 8, and Week 12
Modified Functional Reach (MFR)
Time frame: Week 0, Week 8, and Week 12
Global Rating of Change (GRC)
Time frame: Week 0, Week 8, and Week 12
NeuroRecovery Scale (NRS)
Time frame: Week 0 and Week 4
Demographic Information
Time frame: Week 0
Injury Information
Time frame: Week 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FTP Alone, FTP+Con-FES and FTP+WPHF-FES in people with Cervical Spinal Cord Injury, run by Craig Hospital at 1 site 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 9 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 30 Mar 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Capabilities of Upper Extremity Test (CUE-T) (time frame: Week 0 to Week 12). 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 30 Mar 2026.