C-STAR Movement Database

• Sponsor: Shirley Ryan AbilityLab (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05471375
• Collaborator: (none)
• Enrollment: 250
• Location: 1
• Anticipated Duration (Months): 33
• Patients Per Site Per Month: 7.6

Study Details

Study Description

Brief Summary

The purpose of this study is to develop a database that contains movement and rehabilitation-related data collected through the use of wearable sensors and video. This database will serve as a resource for clinicians and researchers interested in the investigation of movement or rehabilitation-related research ideas.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Parkinson Disease; Lower Limb Amputation Above Knee (Injury); Lower Limb Amputation Below Knee (Injury)	Other: Database Entry

Detailed Description

Scholarly research in the field of physical rehabilitation helps to aid in maximizing outcomes for individuals that require these services due to orthopedic and neurologic injuries. To produce quality research results, large cohorts of individuals are often required for data analysis. Some research facilities or labs do not have adequate access to large cohorts or may not have the means to recruit them. By building the C-STAR database, the intent is to create a database that can serve as a hub for data sets that researchers and clinicians with appropriate access may use to support their research questions related to movement and physical rehabilitation.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 250 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Center for Smart Use of Technologies to Assess Real World Outcomes Movement Database
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Aug 31, 2023
• Anticipated Study Completion Date: Apr 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Stroke For this cohort, individuals who have experienced a stroke will be asked to complete a variety of movement related rehabilitation assessments with wearable sensors and audio/video recording.	Other: Database Entry; Database entries will contain wearable sensor, audio, and video data collected during rehabilitation-related movement assessments
Parkinsons Disease For this cohort, individuals who have been diagnosed with Parkinsons Disease will be asked to complete a variety of movement related rehabilitation assessments with wearable sensors and audio/video recording.	Other: Database Entry; Database entries will contain wearable sensor, audio, and video data collected during rehabilitation-related movement assessments
Lower Limb Amputation For this cohort, individuals who have experienced a lower limb amputation will be asked to complete a variety of movement related rehabilitation assessments with wearable sensors and audio/video recording.	Other: Database Entry; Database entries will contain wearable sensor, audio, and video data collected during rehabilitation-related movement assessments
Healthy Control For this cohort, individuals who have no significant neurologic or orthopedic injuries will be asked to complete a variety of movement related rehabilitation assessments with wearable sensors and audio/video recording.	Other: Database Entry; Database entries will contain wearable sensor, audio, and video data collected during rehabilitation-related movement assessments

Outcome Measures

Primary Outcome Measures

1. Database development [Data will be collected and added to the C-STAR database for 3 years]

   To develop an online database that contains movement and rehabilitation-related data collected with wearable sensors and video that may be accessed, with appropriate permissions, by clinicians and researchers that are interested in the investigation of movement or rehabilitation related research ideas.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 99 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

1. Age 0 to 99 years old

2. Able and willing to give written consent and comply with study procedures

Exclusion Criteria:

1. Unable to give written consent or comply with study procedures

2. Any condition that would prevent safe completion of study activities, as determined by the Principal Investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shirley Ryan AbilityLab	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Shirley Ryan AbilityLab

Investigators

• Principal Investigator: Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
• Principal Investigator: Levi Hargrove, PhD, Shirley Ryan AbilityLab
• Principal Investigator: Richard Lieber, PhD, Shirley Ryan AbilityLab

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Arun Jayaraman, PT, PhD, Principal Investigator, Shirley Ryan AbilityLab
• ClinicalTrials.gov Identifier: NCT05471375
• Other Study ID Numbers: STU00216350
• First Posted: Jul 22, 2022
• Last Update Posted: Jul 22, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Parkinson Disease; Wounds and Injuries

Study Results

No Results Posted as of Jul 22, 2022