Clinical trial NCT04000256: Understanding Experiences of People With Spinal Cord Injury Undergoing Activity-based Rehabilitation
Official title: Understanding Experiences of People With Spinal Cord Injury Undergoing Activity-based Rehabilitation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Cord Injuries
Keywords: Spinal cord injuries
Telerehabilitation
Qualitative
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2019-06-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults 18 years or older with chronic stable cervical spinal cord injury affecting one or both arms

Brief summary: Incomplete cervical spinal cord injury (SCI) makes up half of all the newly admitted patients. For these individuals, the use of their upper limbs is critical for managing daily activities and self-care and impacts their quality of life. For home-based monitored rehabilitation, also called telerehabilitation, there are various rehabilitation equipment that are used. No studies have systematically gathered information regarding the perceptions of individuals with SCI regarding these equipment, training, and feasibility within the home. Further, their perceptions of the usability of high vs low end equipment is also not explored. In this study, investigators plan to gather survey and interview data from individuals with SCI regarding their experience with using rehabilitation equipment that uses games, muscle stimulation, and object manipulation. This study will inform the development of a tele-rehabilitation intervention in the future.

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.

Eligibility criteria: Inclusion Criteria:

1. Motor incomplete cervical SCI, neurologic levels C1-C7
2. Atleast one arm with active shoulder flexion (reach with gravity eliminated) and atleast one grasp pattern/able to move fingers
3. At least 6 months post injury
4. 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
5. Medically stable with no contraindications to the activities or to sitting
6. 18 years of age or older

Exclusion Criteria:

1. Uncontrolled pain in the upper limbs
2. Upper extremity amputations
3. Unable to commit to at least 3 visits
4. Surgical procedures (e.g., tendon transfers) or orthopedic trauma (e.g., fracture) within the past 3 months
5. Other neurological conditions
6. Mechanical Ventilation

Primary outcomes:
measure: 10-item questionnaire
timeFrame: Week 4
Secondary outcomes:
measure: Qualitative interview
timeFrame: Week 4
measure: Qualitative interview
timeFrame: Week 2
measure: 10-item questionnaire
timeFrame: Week 2
Other outcomes:
Locations:
city: Orange
country: United States
facility: Chapman University
state: California
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Ralph Marino, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.