CLINICAL TRIAL

Engagement in a 8-week community-based activity program for Cerebral Palsy

Waitlist Available · < 65 · All Sexes · Montreal, Canada

NCT04288453

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About the trial for Cerebral Palsy

Eligible Conditions
Musculoskeletal Disorders · Spinal Dysraphism · Spina Bifida · Musculoskeletal Diseases · Cerebral Palsy

Treatment Groups

This trial involves 2 different treatments. Engagement In A 8-week Community-based Activity Program is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Engagement in a 8-week community-based activity program
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 65 and younger. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
have a physical disability (e.g., cerebral palsy, spina bifida, musculoskeletal disorders)
restricted mobility, such as an inability to navigate all surfaces and stairs independently and safely without the use of aids, physical assistance or external support
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 22 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 22 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Engagement in a 8-week community-based activity program will improve 6 primary outcomes and 1 other outcome in patients with Cerebral Palsy. Measurement will happen over the course of This outcome will be assessed once at baseline only (week 1)..

Life-Habits (LIFE-H)
THIS OUTCOME WILL BE ASSESSED ONCE AT BASELINE ONLY (WEEK 1).
Evaluates participation accomplishments in daily activities and social roles using a 4-point scale. Scores range from 1 (not accomplished) to 4 (accomplished with no difficulty).
Functional Reach Test
22 WEEKS
Assesses motor body functions in terms of reaching. The maximum distance in inches the participant can reach forward while standing/sitting in a fixed position is measured; units: inches.
Canadian Occupational Performance Measure
22 WEEKS
10-point scale that measures activity performance. Score ranges from 1 (unable to perform) to 10 (performs extremely well).
Trunk Impairment Scale
22 WEEKS
Assesses trunk control and includes 3 sub-scales; static sitting balance, dynamic sitting balance and coordination. It contains 17 items rated on a 2-, 3- or 4- point scale. Total score measures motor body functions in terms of trunk control. Total score ranges from 0 (low performance) to 23 (high performance).
Goniometer
22 WEEKS
Measures active range of motion of specific joints relevant to the activity and based on the task analysis; units: degrees of range of motion.
Behavioral Assessment System for Children
22 WEEKS
Evaluates cognitive and affective body functions using a 4-point scale. T-scores range from 0 to 120 in which lower scores indicate greater cognitive and affective body functions.
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Who is running the study

Principal Investigator
D. A.
Prof. Dana Anaby, Associate Professor
McGill University

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is cerebral palsy?

The impact of [cerebral palsy](https://www.withpower.com/clinical-trials/cerebral-palsy) on children is huge and can have an adverse effect on a child's educational ability and social interactions. CP also can have several physical effects that may affect a child for the rest of his or her lifetime. The exact number of children affected with CP is unknown but it is believed to affect about 300,000 children in the United Kingdom. Although CP has been found to be common amongst children, it remains under-reported as there are many symptoms of CP that are not appreciated on a casual basis.\n

Anonymous Patient Answer

How many people get cerebral palsy a year in the United States?

Around 1.8 million people are diagnosed with CP annually in the US. The majority are diagnosed neonatally, but the rate of older onset CP is higher in the US than in most developed countries.

Anonymous Patient Answer

What are common treatments for cerebral palsy?

There is great variability in the treatments of cerebral palsy. Rehabilitation treatments are often very expensive, even when many are needed. The only commonly-accepted treatments are surgery and physical therapies such as braces, casting, splinting, electrical stimulation, and occupational therapy. Children who are not ambulatory can often return to their families and their usual home life. Some children may be hospitalized because the need for the intensive physical and occupational therapy is more than the cost of outpatient care. Asymmetry of the limbs may make casting, surgery, and many other physical treatments difficult to implement comfortably. Children whose cerebral palsy is more moderate typically need some physical and occupational therapy.

Anonymous Patient Answer

Can cerebral palsy be cured?

The evidence to support this question was largely lacking; the answer was essentially that there are a number of factors that can affect the brain including environment, which play major role in development, nutrition and in health and wellbeing, and the interaction of the brain with the environment. Some treatments like stem-cell therapy are being investigated, which are aimed at restoring function and functionality of the nervous system.\n\nIn the world of science fiction, a hypothetical disease called "Creutzfeldt–Jakob disease" (CJD) has been used as the basis for most fictional depictions of the condition, often as a type of "crazy person's disease".

Anonymous Patient Answer

What are the signs of cerebral palsy?

As with any complex healthcare requirement, there will be many combinations of signs and symptoms which make up most cases of CP. These will be summarised for use to facilitate assessment and provide the patient information and support essential for the delivery of quality, evidence-based care. Inclusion in CP assessments will be facilitated by using a structured clinical interview and review of historical records.

Anonymous Patient Answer

What causes cerebral palsy?

The most commonly accepted theory of CP pathogenesis is that CP results from poor fetal brain function. While it is still possible that other factors contribute to the development of CP, or the timing of brainstem dysfunction. The pathogenic mechanisms of CP leading to neuronal damage are not fully understood. The development of safe and effective therapies remains a persistent challenge in neonatal medicine.

Anonymous Patient Answer

Does cerebral palsy run in families?

family history of cerebral palsy does not run in families at least among the family unit in which we studied. This contradicts the common notion that cerebral palsy has an autosomal dominant pattern of inheritance.

Anonymous Patient Answer

Has engagement in a 8-week community-based activity program proven to be more effective than a placebo?

Participation in a community-based program has led to improvements that are evident in HRQoL, health-related fatigue, and functioning in people with CP. This provides evidence that community-based activity programs can be effective in engaging people with CP.

Anonymous Patient Answer

Who should consider clinical trials for cerebral palsy?

Cerebral palsy can be managed by patients, families and their caregivers, health care providers, and researchers. Clinical trials can be used to compare outcomes from different treatment perspectives (e.g. patient and caregiver treatment experiences, as well as comparing patient- and family-centered interventions.

Anonymous Patient Answer

What are the latest developments in engagement in a 8-week community-based activity program for therapeutic use?

Rehabilitation can be a promising mode of intervention to change the activity profiles of individuals with cerebral palsy. Individualized exercise programs for this population should be encouraged to continue to be developed.

Anonymous Patient Answer

How does engagement in a 8-week community-based activity program work?

This trial demonstrates that engaging in a program of community-based activity improves perceived health and health-related self-efficacy and that these results translate into improved exercise habits among people with disability.

Anonymous Patient Answer

Is engagement in a 8-week community-based activity program safe for people?

Participation in an 8-wk self-monitoring physical activity intervention may not lead to adverse effects for older adults. Although these findings do not preclude adverse effects for young adults, this self-guided program may be appropriate for both age-groups as these are populations most likely to benefit from the program.

Anonymous Patient Answer
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