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Sensory Stimulation During CIMT

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ClinicalTrials.gov Identifier: NCT03558230
Recruitment Status : Completed
First Posted : June 15, 2018
Results First Posted : March 8, 2019
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cerebral Palsy
Interventions Behavioral: Standardized Constraint-Induced Movement Therapy
Behavioral: Vibration
Behavioral: Placebo (for vibration)
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vibration No Vibration
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 7 6
Completed 7 6
Not Completed 0 0
Arm/Group Title Vibration No Vibration Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 7 6 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 6 participants 13 participants
5.7  (1.8) 5.5  (1.9) 5.6  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
Female
3
  42.9%
6
 100.0%
9
  69.2%
Male
4
  57.1%
0
   0.0%
4
  30.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
7
 100.0%
6
 100.0%
13
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  16.7%
1
   7.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  14.3%
1
  16.7%
2
  15.4%
White
6
  85.7%
3
  50.0%
9
  69.2%
More than one race
0
   0.0%
1
  16.7%
1
   7.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Feasibility (Total Number of Hours That Participants Wear the Device)
Hide Description total number of hours that participants wear the device
Time Frame through 5-day study completion.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vibration No Vibration
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 7 6
Mean (Standard Deviation)
Unit of Measure: Hours
28.3  (0.3) 27.9  (1)
Time Frame Throughout the 5-day study period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vibration No Vibration
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Vibration No Vibration
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)      0/6 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Vibration No Vibration
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vibration No Vibration
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/7 (28.57%)      1/6 (16.67%)    
Skin and subcutaneous tissue disorders     
Temporary skin redness   2/7 (28.57%)  2 1/6 (16.67%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Na Jin Seo
Organization: Medical University of South Carolina
Phone: 843-792-0084
EMail: seon@musc.edu
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03558230     History of Changes
Other Study ID Numbers: PRO74164
First Submitted: May 7, 2018
First Posted: June 15, 2018
Results First Submitted: November 16, 2018
Results First Posted: March 8, 2019
Last Update Posted: March 8, 2019