Improving Hand and Arm Function After Spinal Cord Injury (SCI)

Spinal Cord Injury Clinical Trial

Official title:

Improving Hand and Arm Function After SCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143597
• Other study ID #: R01HD053854
• Status: Completed
• Phase: N/A
• First received: June 11, 2010
• Last updated: October 9, 2013
• Start date: August 2007
• Est. completion date: August 2013

Study information

• Verified date: October 2013
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 (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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Other:
• Arm and hand training
Individuals will receive either: somatosensory stimulation isolated or combined with a skill-based exercise protocol, or a conventional strengthening program.

Locations

Country	Name	City	State
United States	The Miami Project to Cure Paralysis	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Beekhuizen 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. — View Citation

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. — View Citation

Hoffman 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. Epub 2007 Jan 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks	No
Secondary	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.	4 weeks	No