Spinal Cord InjuryNCT01143597
Improving Hand and Arm Function After Spinal Cord Injury (SCI)
A study testing Arm and hand training in people with Spinal Cord Injury, run by University of Miami at 1 site in United States.
Trial summary
The long-term goal of this project is to develop rehabilitation strategies that facilitate optimal restoration of skilled hand use in individuals with spinal cord injury (SCI). The objective of the studies proposed in this application is to determine whether a protocol of massed practice + somatosensory stimulation… Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Arm and hand training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Aug 2013
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- traumatic spinal cord injury of at least one-year duration
- injury to cervical spinal cord at C7 or higher
- sufficient strength of thenar muscles to generate, at minimum, a visible twitch contraction in at least one thumb
Who cannot join
- history of head trauma and/or cognitive deficit
- subject history of stroke, seizures or other intracranial disease
- family history of seizures
- inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
The Miami Project to Cure Paralysis
Miami, Florida, 33131
About this study
Official title: Improving Hand and Arm Function After SCI
The long-term goal of this project is to develop rehabilitation strategies that facilitate optimal restoration of skilled hand use in individuals with spinal cord injury (SCI). The objective of the studies proposed in this application is to determine whether a protocol of massed practice + somatosensory stimulation (MP+SS) is more effective for improving skilled hand use compared to a somatosensory stimulation (SS) alone, and to determine whether these approaches are each more effective than traditional therapy (consisting of conventional resistance training; CRT).
Specific Aim I: In individuals with chronic incomplete tetraplegia, quantify changes in skilled hand use and sensory function associated with either: massed practice training combined with somatosensory stimulation (MP+SS), somatosensory stimulation (SS), or control (conventional resistance training [CRT]), and compare differences among groups. The investigators hypothesize that:
Read more
H1.1: At the end of 4 weeks, gains in scores on standardized tests of skilled hand motor function (Jebsen-Taylor Hand Function Test and Chedoke-McMaster Arm and Hand Activity Inventory) and sensory function (quantitative sensory tests; QST) will be greater in individuals who are trained using MP+SS compared to the SS and RT groups.
H1.2: At the end of 4 weeks, gains in scores on standardized tests of skilled hand motor function and sensory function tests will be greater in individuals who are trained using SS compared to CRT.
H1.3: At 6 months post training, motor and sensory gains will be retained by the MP+SS and SS groups.
Specific Aim 2: In individuals with chronic incomplete tetraplegia, quantify changes in cortical and spinal neurophysiology associated with either: massed practice combined with somatosensory stimulation (MP+SS), somatosensory stimulation (SS), or control (conventional resistance training [CRT]), and compare differences among groups. The investigators hypothesize that, after 4 weeks:
H2.1: Measures representing cortical neurophysiologic function (i.e., motor-evoked potential amplitude and location of cortical map) will show greater change in the direction of more normal values in individuals who are trained using MP+SS compared to the SS and the CRT groups.
H2.2: Measures representing spinal neurophysiologic function (i.e., F-wave and H-reflex amplitude) will show greater change in the direction of more normal values in individuals who are trained using SS compared to the MP+SS and the CRT groups.
H2.3: There will be a positive relationship between change scores associated with functional outcome measures and cortical neurophysiologic outcome measures in the MP+SS group; there will be a positive relationship between change scores associated with the functional outcome measures and spinal neurophysiologic outcome measures in the SS group.
Specific Aim 3: In individuals with chronic incomplete tetraplegia, quantify changes in self-assessment of quality of life and societal participation associated with massed practice combined with somatosensory stimulation (MP+SS), somatosensory stimulation (SS) or control (conventional resistance training [CRT]), and compare difference among groups. The investigators hypothesize that:
H3.1: Gains in scores on standardized measures of quality of life (Medical Outcomes Study Short Form 36 [SF-36]) and societal participation (Impact on Participation and Autonomy Questionnaire [IPAQ]) will be greater in individuals who are trained using MP+SS compared to both the SS and the CRT groups.
H3.2: Gains in scores on standardized measures of quality of life and societal participation will be greater in individuals who are trained using SS compared to the CRT group.
H3.3: At 6 months post training, gains in the quality of life and the societal participation measures will be retained by the MP+SS and SS groups.
Risks: This is a low risk study that investigates the effects of standard rehabilitation and exercise interventions on hand/arm function in individuals with SCI. All devices are considered minimal risk devices by the FDA.
Read the detailed description
Evidence suggests that both intensive, skill-based practice training combined with somatosensory stimulation (MP+SS) and somatosensory stimulation alone (SS) may be associated with functional changes that are greater than those associated with skill-based training alone (MP). These studies are significant in that they advance the field of rehabilitation science as it relates to the goal of improving skilled hand use in individuals with SCI; there are few goals that have more important implications for function, independence and quality of life in these individuals.
- Conditions
- Spinal Cord Injury
- Being tested
- Arm and hand training
- Keywords
- task-specific training, arm and hand function, corticomotor plasticity, individuals with motor-incomplete spinal cord injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm and hand trainingOther
Individuals will receive either: somatosensory stimulation isolated or combined with a skill-based exercise protocol, or a conventional strengthening program.
| Study group | Role | What they receive |
|---|---|---|
| Somatosensory stimulation (SS) | Active comparator | Participants in the SS group receive median nerve electrical stimulation applied to the skin of the wrists. Receives: Other: Arm and hand training |
| Massed practice + somatosensory stimulation (MP+SS) | Active comparator | Participants in the MP+SS group receive a combined intervention consisting of SS and a skill-based exercise protocol Receives: Other: Arm and hand training |
| Conventional resistance training (CRT) | Active comparator | Participants in the CRT group will participate in a weight-based exercise program Receives: Other: Arm and hand training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Jebsen-Taylor Hand Function Test
The Jebsen Test is an assessment of hand function and improvement in hand function associated with therapeutic procedures. Individuals with cervical SCI are included in the target population for use of the test. The test is comprised of 7 subtests, including writing, turning over cards, picking up small common objects, simulated feeding, stacking checkers, picking up large light objects, and picking up large heavy objects.
Measured: 4 weeks
Secondary outcomes (1)
Cortical motor excitability via transcranial magnetic stimulation (TMS)
The motor threshold (intensity required to evoke 5/10 motor evoked potentials), a recruitment curve (from 80% of the motor threshold to the maximum stimulator output, in increments of 20%), and the thenar motor map (number of active sites for the thenar muscles in the hand motor cortical distribution) will be recorded via TMS.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startAug 2007
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Edelle Field-Fote, University of Miami
- Investigators
- Edelle C Field-Fote, PT, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143597
- Sponsor's protocol ID
- R01HD053854
- Status last verified
- Oct 2013
- First submitted
- 11 Jun 2010
- Last updated
- 10 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Beekhuizen KS, Field-Fote EC. Sensory stimulation augments the effects of massed practice training in persons with tetraplegia. Arch Phys Med Rehabil. 2008 Apr;89(4):602-8. doi: 10.1016/j.apmr.2007.11.021.
PubMed 18373988Hoffman LR, Field-Fote EC. Cortical reorganization following bimanual training and somatosensory stimulation in cervical spinal cord injury: a case report. Phys Ther. 2007 Feb;87(2):208-23. doi: 10.2522/ptj.20050365. Epub 2007 Jan 9.
PubMed 17213410Beekhuizen KS, Field-Fote EC. Massed practice versus massed practice with stimulation: effects on upper extremity function and cortical plasticity in individuals with incomplete cervical spinal cord injury. Neurorehabil Neural Repair. 2005 Mar;19(1):33-45. doi: 10.1177/1545968305274517.
PubMed 15673842
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Hand and Arm Function After SCI
- ClinicalTrials.gov ID
- NCT01143597
- Acronym / sponsor ID
- R01HD053854
- Conditions
- Spinal Cord Injury
- Keywords
- task-specific training, arm and hand function, corticomotor plasticity, individuals with motor-incomplete spinal cord injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Aug 2007
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 14 Jun 2010 (estimated)
- 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.
The long-term goal of this project is to develop rehabilitation strategies that facilitate optimal restoration of skilled hand use in individuals with spinal cord injury (SCI). The objective of the studies proposed in this application is to determine whether a protocol of massed practice + somatosensory stimulation (MP+SS) is more effective for improving skilled hand use compared to a somatosensory stimulation (SS) alone, and to determine whether these approaches are each more effective than traditional therapy (consisting of conventional resistance training; CRT).
Specific Aim I: In individuals with chronic incomplete tetraplegia, quantify changes in skilled hand use and sensory function associated with either: massed practice training combined with somatosensory stimulation (MP+SS), somatosensory stimulation (SS), or control (conventional resistance training [CRT]), and compare differences among groups. The investigators hypothesize that:
H1.1: At the end of 4 weeks, gains in scores on standardized tests of skilled hand motor function (Jebsen-Taylor Hand Function Test and Chedoke-McMaster Arm and Hand Activity Inventory) and sensory function (quantitative sensory tests; QST) will be greater in individuals who are trained using MP+SS compared to the SS and RT groups.
H1.2: At the end of 4 weeks, gains in scores on standardized tests of skilled hand motor function and sensory function tests will be greater in individuals who are trained using SS compared to CRT.
H1.3: At 6 months post training, motor and sensory gains will be retained by the MP+SS and SS groups.
Specific Aim 2: In individuals with chronic incomplete tetraplegia, quantify changes in cortical and spinal neurophysiology associated with either: massed practice combined with somatosensory stimulation (MP+SS), somatosensory stimulation (SS), or control (conventional resistance training [CRT]), and compare differences among groups. The investigators hypothesize that, after 4 weeks:
H2.1: Measures representing cortical neurophysiologic function (i.e., motor-evoked potential amplitude and location of cortical map) will show greater change in the direction of more normal values in individuals who are trained using MP+SS compared to the SS and the CRT groups.
H2.2: Measures representing spinal neurophysiologic function (i.e., F-wave and H-reflex amplitude) will show greater change in the direction of more normal values in individuals who are trained using SS compared to the MP+SS and the CRT groups.
H2.3: There will be a positive relationship between change scores associated with functional outcome measures and cortical neurophysiologic outcome measures in the MP+SS group; there will be a positive relationship between change scores associated with the functional outcome measures and spinal neurophysiologic outcome measures in the SS group.
Specific Aim 3: In individuals with chronic incomplete tetraplegia, quantify changes in self-assessment of quality of life and societal participation associated with massed practice combined with somatosensory stimulation (MP+SS), somatosensory stimulation (SS) or control (conventional resistance training [CRT]), and compare difference among groups. The investigators hypothesize that:
H3.1: Gains in scores on standardized measures of quality of life (Medical Outcomes Study Short Form 36 [SF-36]) and societal participation (Impact on Participation and Autonomy Questionnaire [IPAQ]) will be greater in individuals who are trained using MP+SS compared to both the SS and the CRT groups.
H3.2: Gains in scores on standardized measures of quality of life and societal participation will be greater in individuals who are trained using SS compared to the CRT group.
H3.3: At 6 months post training, gains in the quality of life and the societal participation measures will be retained by the MP+SS and SS groups.
Risks: This is a low risk study that investigates the effects of standard rehabilitation and exercise interventions on hand/arm function in individuals with SCI. All devices are considered minimal risk devices by the FDA.
Detailed description
Evidence suggests that both intensive, skill-based practice training combined with somatosensory stimulation (MP+SS) and somatosensory stimulation alone (SS) may be associated with functional changes that are greater than those associated with skill-based training alone (MP). These studies are significant in that they advance the field of rehabilitation science as it relates to the goal of improving skilled hand use in individuals with SCI; there are few goals that have more important implications for function, independence and quality of life in these individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Somatosensory stimulation (SS) | Active comparator | Other: Arm and hand trainingParticipants in the SS group receive median nerve electrical stimulation applied to the skin of the wrists. |
| Massed practice + somatosensory stimulation (MP+SS) | Active comparator | Other: Arm and hand trainingParticipants in the MP+SS group receive a combined intervention consisting of SS and a skill-based exercise protocol |
| Conventional resistance training (CRT) | Active comparator | Other: Arm and hand trainingParticipants in the CRT group will participate in a weight-based exercise program |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- traumatic spinal cord injury of at least one-year duration
- injury to cervical spinal cord at C7 or higher
- sufficient strength of thenar muscles to generate, at minimum, a visible twitch contraction in at least one thumb
Key exclusion criteria (4 listed)
- history of head trauma and/or cognitive deficit
- subject history of stroke, seizures or other intracranial disease
- family history of seizures
- inability to provide informed consent
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 |
|---|---|---|
| Arm and hand trainingIndividuals will receive either: somatosensory stimulation isolated or combined with a skill-based exercise protocol, or a conventional strengthening program. | Other | Conventional resistance training (CRT), Massed practice + somatosensory stimulation (MP+SS), Somatosensory stimulation (SS) |
Primary outcome
The Jebsen-Taylor Hand Function Test
Time frame: 4 weeks
The Jebsen Test is an assessment of hand function and improvement in hand function associated with therapeutic procedures. Individuals with cervical SCI are included in the target population for use of the test. The test is comprised of 7 subtests, including writing, turning over cards, picking up small common objects, simulated feeding, stacking checkers, picking up large light objects, and picking up large heavy objects.
1 secondary outcome
Cortical motor excitability via transcranial magnetic stimulation (TMS)
Time frame: 4 weeks
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 10 Oct 2013.
- Background: PubMed 18373988Beekhuizen KS, Field-Fote EC. Sensory stimulation augments the effects of massed practice training in persons with tetraplegia. Arch Phys Med Rehabil. 2008 Apr;89(4):602-8. doi: 10.1016/j.apmr.2007.11.021.
- Background: PubMed 17213410Hoffman LR, Field-Fote EC. Cortical reorganization following bimanual training and somatosensory stimulation in cervical spinal cord injury: a case report. Phys Ther. 2007 Feb;87(2):208-23. doi: 10.2522/ptj.20050365. Epub 2007 Jan 9.
- Background: PubMed 15673842Beekhuizen KS, Field-Fote EC. Massed practice versus massed practice with stimulation: effects on upper extremity function and cortical plasticity in individuals with incomplete cervical spinal cord injury. Neurorehabil Neural Repair. 2005 Mar;19(1):33-45. doi: 10.1177/1545968305274517.
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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.
Edelle C Field-Fote, PT, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm and hand training in people with Spinal Cord Injury, run by University of Miami 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 3 inclusion and 4 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 10 Oct 2013. 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?
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?
The Jebsen-Taylor Hand Function Test (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01143597, which also lists 3 linked publications.
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 Oct 2013.