- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04000256
Understanding Experiences of People With Spinal Cord Injury Undergoing Activity-based Rehabilitation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Incomplete cervical spinal cord injury (SCI) makes up half of all the newly admitted patients. The overall prognosis for walking is better than the upper limb recovery in incomplete tetraplegia. Upper limb deficits result in difficulty in managing daily activities and self-care and impacts quality of life. Rehabilitation of the upper limb involves high intensity repetitive activities that are directed to a specific task. The demands of these programs can be up to 5 hours of therapy, 5 days a week for 12 weeks. Home-based therapies augmented by tele-rehabilitation presents a more realistic alternative to clinic-based application of these programs due to transportation and time commitment. However, engaging and motivating therapy options are needed for home to enhance client outcomes and improve compliance. Some of the latest equipment provides this capability and engages the patient using games for training. However, high equipment cost limits its widespread use.
In this study, we will engage individuals with cervical SCI in a 4-week (8 visit) evaluation of a variety of training protocols to gather information on their perceptions regarding motivation, engagement, and challenge it offers; its ability to address limitations they experience; and its feasibility within the home.
The long-term goal of this National Institute of Disability Independent Living and Rehabilitation (NIDILRR) funded Spinal Cord Injury Model System (SCIMS) project is to develop an engaging and evidence-informed intervention for home-based upper limb activity-based rehabilitation in individuals with spinal cord injury (SCI). A review of literature was recently conducted by the research team to get a scope of the evidence related to current activity-based therapies and the equipment used to deliver these programs. There is insufficient information about the value of high-end equipment involving games relative to lower cost alternatives, or the perceptions of clients regarding the use of various technologies related to motivation, engagement, appropriate level of difficulty and feasibility within the home. This lab-based study aims to understand the experiences related to rehabilitation training and high and low end equipment for upper limb activity-based rehabilitation in individuals with spinal cord injury.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Namrata Grampurohit, PhD
- Phone Number: 2063536054
- Email: namrata.grampurohit@jefferson.edu
Study Contact Backup
- Name: Ralph Marino, MD
- Phone Number: 215 955-5756
- Email: ralph.marino@jefferson.edu
Study Locations
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California
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Orange, California, United States, 92866
- Chapman University
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Motor incomplete cervical SCI, neurologic levels C1-C7
- Atleast one arm with active shoulder flexion (reach with gravity eliminated) and atleast one grasp pattern/able to move fingers
- At least 6 months post injury
- At least one arm with greater than 50% normal passive range of motion in all upper limb joints, excluding the interphalangeal joints of the fingers
- Medically stable with no contraindications to the activities or to sitting
- 18 years of age or older
Exclusion Criteria:
- Uncontrolled pain in the upper limbs
- Upper extremity amputations
- Unable to commit to at least 3 visits
- Surgical procedures (e.g., tendon transfers) or orthopedic trauma (e.g., fracture) within the past 3 months
- Other neurological conditions
- Mechanical Ventilation
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Spinal Cord Injury
The data during the first visit involves questionnaires, performance and observational measures for baseline evaluation.
The 2nd to 8th visit involves feedback survey and interview data collection based on experiences of participants undergoing activity-based training using upper extremity rehabilitation equipment.
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Activity based rehabilitation for the upper extremity involves various gross and fine movements, reach and object transportation, and object manipulation.
The rehabilitation equipment used during training will include gaming and instrumented training equipment, conventional table-top tasks, and exercise aids.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
10-item questionnaire
Time Frame: Week 4
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Quantitative feedback using a 10-question survey regarding experiences with the rehabilitation training and equipment for feasibility, motivation, engagement and difficulty.
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Week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Qualitative interview
Time Frame: Week 4
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Interview to explore further the experiences with rehabilitation training and equipment.
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Week 4
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Qualitative interview
Time Frame: Week 2
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Interview to explore further the experiences with rehabilitation training and equipment.
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Week 2
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10-item questionnaire
Time Frame: Week 2
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Quantitative feedback using a 10-question survey regarding experiences with the rehabilitation training and equipment for feasibility, motivation, engagement and difficulty.
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Week 2
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ralph Marino, MD, Thomas Jefferson University
Publications and helpful links
General Publications
- Szturm T, Peters JF, Otto C, Kapadia N, Desai A. Task-specific rehabilitation of finger-hand function using interactive computer gaming. Arch Phys Med Rehabil. 2008 Nov;89(11):2213-7. doi: 10.1016/j.apmr.2008.04.021.
- Gauthier LV, Kane C, Borstad A, Strahl N, Uswatte G, Taub E, Morris D, Hall A, Arakelian M, Mark V. Video Game Rehabilitation for Outpatient Stroke (VIGoROUS): protocol for a multi-center comparative effectiveness trial of in-home gamified constraint-induced movement therapy for rehabilitation of chronic upper extremity hemiparesis. BMC Neurol. 2017 Jun 8;17(1):109. doi: 10.1186/s12883-017-0888-0.
- Thielen CC, Marino RJ, Duff S, Kaplan G, Mulcahey MJ. Activity-based Rehabilitation Interventions of the Neurologically Impaired Upper Extremity: Description of a Scoping Review Protocol. Top Spinal Cord Inj Rehabil. 2018 Summer;24(3):288-294. doi: 10.1310/sci2403-288.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19G.279
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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