Cerebral Palsy, To Determine Efficacy of the Headpod
Conditions
Brief summary
Inclusion Criteria: children ages 2 to 14 years with poor head control and non progressive diagnoses. Exclusion criteria: significant change of status i.e. prolonged hospitalization, surgery; inability to tolerate using Headpod. Requires use of Headpod 3x per day for minimum of 15 minutes each time over a 6 month period. Log must be kept documenting usage of the Headpod. Video will be taken to document changes.
Detailed description
Requires usage of the Headpod 3x per day for a minimum of 15 minutes each time. Usage required for 6 month period. Log must be kept documenting usage of the Headpod. Video will be taken on initial trial use, 1 week post trial use, at 3 months post utilization of the Headpod and at 6 months post utilization of the Headpod.
Interventions
DEVICEHeadpod
Adaptive equipment to assist with active head movements
Sponsors
Texas Woman's University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Quasi-experimental, one-way repeated measures design
Eligibility
Sex/Gender
ALL
Age
2 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* non progressive diagnoses with poor head control
Exclusion criteria
* recent prolonged hospitalization; surgery, inability to tolerate wearing the Headpod
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Head Holding Active Time From Baseline to 6 Months | baseline to 6 months | Active time in seconds holding head upright |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Headpod Utilization Use of Headpod for 6 months duration; 3 x per day for a minimum of 15 minutes each time;
Headpod: Adaptive equipment to assist with active head movements | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Headpod Utilization | — |
|---|---|---|
| Active head time | 190.33 seconds STANDARD_DEVIATION 42.31 | — |
| Age, Categorical <=18 years | 14 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Age, Continuous | 7 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 14 Participants | — |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 1 / 14 |
Outcome results
Primary
Change in Head Holding Active Time From Baseline to 6 Months
Active time in seconds holding head upright
Time frame: baseline to 6 months
Population: Children ages 3 to 11 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Headpod Utilization | Change in Head Holding Active Time From Baseline to 6 Months | 83.63 Seconds | Standard Deviation 38.07 |