Chronic Stroke Clinical Trial
Official title:
Can Participants With Chronic Stroke Regain Living Independence by Daily Energizing With a Biophoton Generator
Study objective The purpose of this clinical research is to verify if the patient with chronic stroke can regain the ability of living independently after daily using Testa BioHealing® Biophoton Generators to increase the energy of the brain and other parts of the body. Study design This study is a randomized, triple-blinded, placebo-controlled prospective intervention clinical research. At least 46 patients with chronic stroke will participate in the live-in observational study in a Tesla MedBed Center. Study patient population The adult patient with a chronic stroke which was defined as a stroke occurred at least 6 months ago with a significant disability unable to have an independent life, is to be considered as a qualified participant.
Investigational product and mode of administration The hotel bed is powered by a standardized set of 14 biophoton generators of 32-Oz size, which was previously tested as safe and effective. The active device is FDA registered over-the-counter (OTC) medical device. The device can be used by anyone who wants to increase blood circulation and reduce bodily pains, according to the label claims. For this study, the active or inactive devices will be labeled with individual codes. The participant, caregiver and the study staff cannot know if the hotel room is equipped with a set of active or inactive devices. When the participant is lying on the hotel bed, she/he may or may not receive biophotons. The study physician, participant or the caregiver will record the ADL and other changes, and answer the standard study questionnaires at the baseline, 2, or 4 weeks after study treatment, respectively. Study procedure Each of all participants assigned to the Control or Treatment Group will be continually treated with the current standard of care (SOC), if any. The Control group will use the coded placebo devices, and the Treatment Group will use the coded treatment product. All coded products will be packed with the same container with the same size and weight. Each participant will use the Treatment or Control device at least for 8-hours every day for 4-weeks during sleep and any daytime during the day. Each participant and caregiver will be guided by the study physician to use Katz Index of Independence in Activities of Daily Living (ADL) to measure the level of life independence. The study physician will perform neurological examination. Stroke Impact Scale (SIS) for stroke-specific health status measurement, SF-36 questionnaires (SF-36) to measure life quality, Electroencephalography (EEG) test, and Bio-Well energy test, will be conducted respectively at the baseline, 2 or 4 weeks after the study treatment. SIS and SF-36 questionnaires will be recalled 4 weeks before the baseline for each participant. Comparator and mode of administration The same shape, size, and weight of the device without generating biophoton is to be labelled with individual codes and used as a comparator. The comparator device will be placed in the same way as the Treatment device in the hotel room during the designed study period. Study duration Estimated date of the first participant enrolled: May 2023. The estimated date of the last patient completed: December 2023. The participants randomized in the Control group will be switched to the Treatment after observing the placebo effects for four weeks. They will be treated with the active device for 4-weeks for self-comparison analysis. Duration of treatment Participants in the Control and Treatment Groups will actively participate in the study for 4-weeks. Each participant and caregiver will answer the standard study questionnaires at the baseline, 2 or 4 weeks of the study, respectively. The participants randomized in the Control will participate in the study for a total of 6 weeks. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03780296 -
Implementing Technology Enhanced Real Time Action Observation Therapy in Persons With Chronic Stroke
|
N/A | |
Not yet recruiting |
NCT06057584 -
Effect of Somatosensory Motor Intergration Training on Post-stroke Upper Limb Function.
|
N/A | |
Completed |
NCT03228264 -
A Trial Investigating Telerehabilitation as an add-on to Face-to-face Speech and Language Therapy in Post-stroke Aphasia.
|
N/A | |
Completed |
NCT03531567 -
Game-Based Home Exercise Programs in Chronic Stroke: A Feasibility Study
|
N/A | |
Completed |
NCT02364232 -
Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation
|
N/A | |
Completed |
NCT04121754 -
Post-Stroke Walking Speed and Community Ambulation Conversion Study
|
N/A | |
Completed |
NCT04574687 -
Effects of Action Observation Therapy on Fine Motor Skills of Upper Limb Functions in Chronic Stroke Patients.
|
N/A | |
Recruiting |
NCT04534556 -
Wireless Nerve Stimulation Device To Enhance Recovery After Stroke
|
N/A | |
Recruiting |
NCT04974840 -
Thera-band Resisted Treadmill Training for Chronic Stroke Patients
|
N/A | |
Completed |
NCT04553198 -
Quantifying the Role of Sensory Systems Processing in Post-Stroke Walking Recovery
|
N/A | |
Completed |
NCT04226417 -
Effect of Home Based Transcranial Direct Current Stimulation (tDCS) With Exercise on Upper and Lower Limb Motor Functions in Chronic Stroke
|
N/A | |
Active, not recruiting |
NCT02881736 -
Proprioceptive Deficits and Anomalies in Movement-error Processing in Chronic Stroke Patients
|
N/A | |
Completed |
NCT03208634 -
Rehabilitation Multi Sensory Room for Robot Assisted Functional Movements in Upper-limb Rehabilitation in Chronic Stroke
|
N/A | |
Completed |
NCT05183100 -
Effects of Neurodynamics on Lower Extremity Spasticity - a Study in Chronic Stroke
|
N/A | |
Completed |
NCT03326349 -
Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke
|
N/A | |
Recruiting |
NCT04721860 -
Optimizing Training in Severe Post-Stroke Walking Impairment
|
N/A | |
Recruiting |
NCT06051539 -
Outcomes and Health Economics of Stroke Using Rhythmic Auditory Stimulation
|
N/A | |
Not yet recruiting |
NCT06060470 -
Active Balance and Cardio Care Intervention on Physical and Cardiovascular Health in People With Chronic Stroke
|
N/A | |
Recruiting |
NCT05591196 -
Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke
|
N/A | |
Recruiting |
NCT06116942 -
Magnetic Brain Stimulation and Computer-based Motor Training for Rehabilitation After Stroke
|
N/A |