Understanding Experiences of People With Spinal Cord Injury Undergoing Activity-based Rehabilitation

NCT04000256 | Unknown

• 1 other identifier: 19G.279
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Cord Injuries

Keywords

Spinal cord injuries; Telerehabilitation; Qualitative

Outcome Measures

Primary Outcomes (1)

• 10-item questionnaire

  Quantitative feedback using a 10-question survey regarding experiences with the rehabilitation training and equipment for feasibility, motivation, engagement and difficulty.

  Week 4

Secondary Outcomes (3)

• Qualitative interview

  Week 4

• Qualitative interview

  Week 2

• 10-item questionnaire

  Week 2

Study Arms (1)

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.

Behavioral: Activity based rehabilitation

Interventions

Activity based rehabilitation BEHAVIORAL

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.

Spinal Cord Injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults 18 years or older with chronic stable cervical spinal cord injury affecting one or both arms

You may qualify if:

• 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
• years of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (2)

Chapman University

Orange, California, 92866, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (4)

• 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.

  PMID: 18996252 BACKGROUND

• 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.

  PMID: 28595611 BACKGROUND

• 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.

  PMID: 29997431 BACKGROUND

• Bell A, Grampurohit N, Kains G, Marino RJ. Developing guiding principles for technology-based rehabilitation program by engaging people with motor incomplete tetraplegia. J Neuroeng Rehabil. 2022 Nov 24;19(1):128. doi: 10.1186/s12984-022-01096-2.

  PMID: 36424612 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Ralph Marino, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 27, 2019
• Study Start: June 1, 2019
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 1 year
• Access Criteria: De-identified data only

Locations

US (2)