HandyMotion Treatment Program
DeviceA pair of sensor-based wireless remote controllers to allow the performance of functional exercises and games that target arm movement.
NCT Number: NCT06069999
The goal of this clinical trial is to assess the safety and feasibility of providing extra doses of rehabilitation therapy for persons with a recent stroke, traumatic brain injury (TBI) and/or spinal cord injury (SCI). The therapy treatment targets to improve arm function by introducing telerehabilitation to the bedside of participants during the inpatient rehab admission period. Participants will use a newly developed functional training system (HandyMotion) to access therapy treatment program directly from their hospital room. HandyMotion is a sensor-based training system that can connect to the TV set in the hospital room, enabling patients to access their therapy training program to practice rehab-oriented games and exercises ad libitum, at any time of the day.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
California Rehabilitation Institute, Los Angeles, California, United States
This clinical trial is designed to address 3 specific aims:
Aim 1: To measure the safety of daily bedside telerehabilitation.
Aim 2: To measure the feasibility of daily bedside telerehabilitation.
Aim 3: To derive a preliminary estimate of motor and functional outcomes in patients engaged in daily bedside telerehabilitation. This is an uncontrolled pilot study, and so it is understood that such measures cannot be attributed to the telerehabilitation intervention, however, these measures will describe the clinical course of a patient engaged in this intervention.
Telerehabilitation therapy is delivered over the course of the inpatient rehabilitation stay. A therapist-facing web portal is used for treatment planning and patient monitoring. The treatment approach was initially designed based on an upper-extremity task-specific training manual and Accelerated Skill Acquisition Program.
Each daily 45-minute treatment session is created by a licensed OT or PT and includes:
A. At least 15 min/day of upper extremity exercises. In addition, therapists have the option to incorporate standard exercise equipment (e.g., Theraband or dowels) that can be incorporated into assigned exercises.
B. At least 15 min/day of functional training through games. The study provides 2 controllers with 5 different input devices that are available to drive game play. Games stress various motor control features (e.g., varying movement speed, range of motion, target size, extent of visuomotor tracking, or level of cognitive demand), which are selected and adjusted by the therapist.
C. If applicable, 5 minutes/day of stroke education. The education content targets five categories (Stroke Risk Factors, Stroke Prevention, Effects of Stroke, Diet, and Exercise) and corresponds to the Stroke Knowledge Exam.
The remaining 10-15 minutes consist of additional exercises and games, per the judgment of the licensed OT or PT.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A pair of sensor-based wireless remote controllers to allow the performance of functional exercises and games that target arm movement.
Time frame: "For approximately 4 weeks, up until discharge"
Safety will be measured in terms of adverse events (AEs) deemed related to use of the telerehabilitation system on a probable or definite basis.
Time frame: "baseline" and "immediately after end of treatment"
Feasibility will be measured in terms of patient compliance, specifically the fraction of days where a patient is assigned to do bedside telerehabilitation and initiates a treatment session. Any factors related to reduced compliance, including technical and medical factors, will be recorded.
Feasibility is a composite measure. It is descriptive, so that all of these observations can be combined into a single outcome.
Time frame: "baseline" and "immediately after end of treatment"
Measure of Upper Extremity Function by assessing unilateral gross manual dexterity.
Participants will be asked to perform the test twice for each side to assess bilateral gross manual dexterity. Participants will be asked to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds.
TRCare, Inc.
Industry
Bedside Telerehabilitation Early After CNS Injury
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02795052
ALS, Alzheimer Disease
Westport, Connecticut, United States
View Trial DetailsNCT04465019
Brain Diseases, Brain Injuries
Edinburg, Texas, United States
View Trial DetailsNCT05691244
Acute Ischemic Stroke, Brain Diseases
Tucson, Arizona, United States
View Trial DetailsNCT07492849
Atrophy, Brain Diseases
Kaohsiung City, Taiwan
View Trial Details