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The long-term goal of this project is to assess the impact of the novel sensory stimulation technique in enhancing outcomes of constraint-induced movement therapy (CIMT) in children with cerebral palsy. This is a pilot project.
The stimulation is peripheral sensory stimulation involving application of low-level, random-frequency vibration to the wrist skin. The hypothesis is that improvement in upper extremity function will be greater for the experimental group receiving the stimulation during CIMT compared with the control group who will wear the device with no vibration (placebo). This pilot study is to assess feasibility and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vibration | Experimental | The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy. |
|
| No Vibration | Placebo Comparator | The control group will wear the vibration device with no vibration during standardized Constraint-Induced Movement Therapy.
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized Constraint-Induced Movement Therapy | Behavioral | The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility (Total Number of Hours That Participants Wear the Device) | total number of hours that participants wear the device | through 5-day study completion. |
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| Name | Affiliation | Role |
|---|---|---|
| Na Jin Seo, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29403 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vibration | The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy. Standardized Constraint-Induced Movement Therapy: The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days. Vibration: Vibration applied to the wrist. The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose. |
| FG001 | No Vibration | The control group will wear the vibration device with no vibration during standardized Constraint-Induced Movement Therapy. Standardized Constraint-Induced Movement Therapy: The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days. Placebo (for vibration): No vibration applied to the wrist. The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vibration | The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy. Standardized Constraint-Induced Movement Therapy: The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days. Vibration: Vibration applied to the wrist. The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility (Total Number of Hours That Participants Wear the Device) | total number of hours that participants wear the device | Posted | Mean | Standard Deviation | Hours | through 5-day study completion. |
|
Throughout the 5-day study period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vibration | The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy. Standardized Constraint-Induced Movement Therapy: The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days. Vibration: Vibration applied to the wrist. The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Temporary skin redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Na Jin Seo | Medical University of South Carolina | 843-792-0084 | seon@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 24, 2018 | Nov 16, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D014732 | Vibration |
| ID | Term |
|---|---|
| D055595 | Mechanical Phenomena |
| D055585 | Physical Phenomena |
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A double-blinded stratified randomized controlled trial
| Vibration | Behavioral | Vibration applied to the wrist. |
|
| Placebo (for vibration) | Behavioral | No vibration applied to the wrist. |
|
| BG001 | No Vibration | The control group will wear the vibration device with no vibration during standardized Constraint-Induced Movement Therapy. Standardized Constraint-Induced Movement Therapy: The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days. Placebo (for vibration): No vibration applied to the wrist. The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
The control group will wear the vibration device with no vibration during standardized Constraint-Induced Movement Therapy. Standardized Constraint-Induced Movement Therapy: The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days. Placebo (for vibration): No vibration applied to the wrist. The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose. |
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 2 |
| 7 |
| EG001 | No Vibration | The control group will wear the vibration device with no vibration during standardized Constraint-Induced Movement Therapy. Standardized Constraint-Induced Movement Therapy: The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days. Placebo (for vibration): No vibration applied to the wrist. The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose. | 0 | 6 | 0 | 6 | 1 | 6 |
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