Load Experienced While Using a Stander in Children With Cerebral Palsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this project is to design and validate a force-measuring platform that will measure the magnitude and duration of the load experienced by the lower extremities of individuals with a neuromuscular disability who use a stationary assisted standing device to increase their Bone Mineral Density.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Quantifying Patient-Specific Changes in Neuromuscular Control in Cerebral Palsy

NCT02699554

Cerebral Palsy

COMPLETED

Effects of Standing on Non-Ambulatory Children With Neuromuscular Conditions

NCT02428673

Osteopenia Spinal Muscular Atrophy Cerebral Palsy +3 more

COMPLETED NA

Augmenting Ankle Plantarflexor Function in Cerebral Palsy

NCT05154253

Cerebral Palsy

RECRUITING PHASE1

Ankle Foot Orthosis on Muscle Activity in Cerebral Palsy

NCT06291974

Cerebral Palsy Spastic Diplegia

NOT_YET_RECRUITING

Quantifying Energetic Demands of Walking for People With Cerebral Palsy

NCT04303078

Cerebral Palsy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Non-ambulatory children with a neuromuscular disability are at significant risk for poor bone health as reflected by low bone mineral density (BMD) and increased propensity to fracture. In large part, this is due to abnormally low levels of load experienced by the skeleton. A common approach for increasing BMD is to stimulate the musculoskeletal system by increasing the amount and duration of weight-bearing in the lower extremities. For non-ambulatory individuals, this typically takes the form of using an assisted standing device to enable the child to spend time in a standing position so that their lower limbs can experience some degree of body weight. Some of these physical interventions result in varying degrees of improvement in BMD, and some do not. This lack of clarity in outcomes may result from a failure to objectively measure the magnitude and duration of the load experienced by the lower extremities. A lack of change in BMD may be due to the extremities experiencing only a fraction of the body weight due to load-sharing with the assistive device, or to an inadequate duration of standing time. The goal of this project will be to design and validate a force-measuring platform that will measure the magnitude and duration of the load experienced by the lower extremities of individuals with a neuromuscular disability who use a stationary assisted standing device to increase their BMD.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Palsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Force-measuring platform

A force-measure platform will be placed under each foot of the subject to record the time course of load borne by each of the lower extremities during weight-bearing training in an assisted standing device.

Intervention: Assisted Standing Treatment Program. Assisted standing treatment program will include at least 2 hours a day, 5 days a week (a total of at least 10 hours a week) for a period of \~9 months.

Group Type OTHER

Assisted Standing Treatment Program

Intervention Type OTHER

Assisted standing treatment program will include at least 2 hours a day, 5 days a week (a total of at least 10 hours a week) for a period of \~9 months.

Arm: Force-measuring platform

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Assisted Standing Treatment Program

Assisted standing treatment program will include at least 2 hours a day, 5 days a week (a total of at least 10 hours a week) for a period of \~9 months.

Arm: Force-measuring platform

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. \< 18 years old
2. Diagnosed with Cerebral Palsy (CP)
3. Treated at Gillette Children's Specialty Healthcare
4. Gross Motor Function Classification System level of IV or V (non-ambulatory without assistance)
5. Participating in a standing program using a stationary assisted standing device
6. Parent/Guardian willing and able to give consent