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出境医 / 临床实验 / Understanding Experiences of People With Spinal Cord Injury Undergoing Activity-based Rehabilitation

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

Study Description
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.

Condition or disease Intervention/treatment
Spinal Cord Injuries Behavioral: Activity based rehabilitation

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 Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Understanding Experiences of People With Spinal Cord Injury Undergoing Activity-based Rehabilitation
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : June 15, 2020
Arms 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.
 Behavioral: Activity based rehabilitation
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.
Outcome Measures
Primary Outcome Measures :
  1. 10-item questionnaire [ Time Frame: Week 4 ]
    Quantitative feedback using a 10-question survey regarding experiences with the rehabilitation training and equipment for feasibility, motivation, engagement and difficulty.


Secondary Outcome Measures :
  1. Qualitative interview [ Time Frame: Week 4 ]
    Interview to explore further the experiences with rehabilitation training and equipment.

  2. Qualitative interview [ Time Frame: Week 2 ]
    Interview to explore further the experiences with rehabilitation training and equipment.

  3. 10-item questionnaire [ Time Frame: Week 2 ]
    Quantitative feedback using a 10-question survey regarding experiences with the rehabilitation training and equipment for feasibility, motivation, engagement and difficulty.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults 18 years or older with chronic stable cervical spinal cord injury affecting one or both arms
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
Contacts and Locations

Contacts
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Contact: Namrata Grampurohit, PhD 2063536054 namrata.grampurohit@jefferson.edu
Contact: Ralph Marino, MD 215 955-5756 ralph.marino@jefferson.edu

Locations
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United States, California
Chapman University Recruiting
Orange, California, United States, 92866
Contact: Susan Duff, EdD    714-997-6794    duff@chapman.edu   
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Namrata Grampurohit, PhD    206-353-6054    namrata.grampurohit@jefferson.edu   
Principal Investigator: Ralph Marino, MD         
Sponsors and Collaborators
Thomas Jefferson University
National Institute on Disability, Independent Living, and Rehabilitation Research
Investigators
Layout table for investigator information
Principal Investigator: Ralph Marino, MD Thomas Jefferson University
Tracking Information
First Submitted Date June 17, 2019
First Posted Date June 27, 2019
Last Update Posted Date June 27, 2019
Actual Study Start Date June 1, 2019
Estimated Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 25, 2019) 		10-item questionnaire [ Time Frame: Week 4 ]
Quantitative feedback using a 10-question survey regarding experiences with the rehabilitation training and equipment for feasibility, motivation, engagement and difficulty.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 25, 2019)
  • Qualitative interview [ Time Frame: Week 4 ]
    Interview to explore further the experiences with rehabilitation training and equipment.
  • Qualitative interview [ Time Frame: Week 2 ]
    Interview to explore further the experiences with rehabilitation training and equipment.
  • 10-item questionnaire [ Time Frame: Week 2 ]
    Quantitative feedback using a 10-question survey regarding experiences with the rehabilitation training and equipment for feasibility, motivation, engagement and difficulty.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults 18 years or older with chronic stable cervical spinal cord injury affecting one or both arms
Condition Spinal Cord Injuries
Intervention Behavioral: Activity based rehabilitation
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.
Study Groups/Cohorts 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.
Intervention: Behavioral: Activity based rehabilitation
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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 25, 2019) 		20
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 15, 2020
Estimated Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04000256
Other Study ID Numbers 19G.279
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Participant data from both sites will be pooled for analysis and reporting of results
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 1 year
Access Criteria: De-identified data only
Responsible Party Thomas Jefferson University
Study Sponsor Thomas Jefferson University
Collaborators National Institute on Disability, Independent Living, and Rehabilitation Research
Investigators
Principal Investigator: Ralph Marino, MD Thomas Jefferson University
PRS Account Thomas Jefferson University
Verification Date June 2019

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