Feasibility and Effectiveness of Therapy Together

NCT ID: NCT07225673

Last Updated: 2025-11-10

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

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-02

Study Completion Date

2026-09-30

Brief Summary

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this study proposes to compare the feasibility and effectiveness of 2 methods of delivery of Therapy Together, a caregiver and child intensive upper limb therapy program for children with CP and children at risk for developing CP ages 3 months - 4 years 11 months.

Detailed Description

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One group will complete 32 hours onsite (4 hour weekly sessions) and 30 minutes of therapeutic activity at home, and the second group will complete 8 hours onsite and 1 hour of therapeutic activity at home. Both groups will aim to complete 56 hours of the intervention.

The Therapy Together program includes caregiver education and coaching on implementing therapeutic activities that are play-based, age-appropriate, and tailored to meet goals to improve arm/hand function. The child and caregiver complete 8 coaching sessions. The first 7 intervention visits focus on constraint-induced movement therapy (CIMT) and the final intervention visit focuses on bimanual therapy (use of two hands).

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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4 hour group

The 4-hour group completed 32 hours in clinic and 24 hours at home (30 minutes per day) to complete the Therapy Together program.

Group Type ACTIVE_COMPARATOR

Therapy Together - 4 hour group

Intervention Type BEHAVIORAL

a caregiver partnered constraint induced movement therapy program

1 hour group

The 1-hour group completed 8 hours of in-clinic therapy and 48 hours of home-based activities (1 hour per day) to complete the Therapy Together program.

Group Type ACTIVE_COMPARATOR

Therapy Together - 1 hour group

Intervention Type BEHAVIORAL

a caregiver partnered constraint induced movement therapy program

Interventions

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Therapy Together - 4 hour group

a caregiver partnered constraint induced movement therapy program

Intervention Type BEHAVIORAL

Therapy Together - 1 hour group

a caregiver partnered constraint induced movement therapy program

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* present with asymmetric hand
* at risk for developing CP or children that have been diagnosed with CP
* must be able to visually attend to objects
* demonstrate an interest in objects
* attempt to reach for or grasp them with the impaired upper extremity

Exclusion Criteria

* uncontrolled epilepsy
* significant visual impairment
* severe behavioral problems
* inability to complete the assessment protocol
Minimum Eligible Age

3 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Texas Scottish Rite Hospital for Children

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angela Shierk

Role: PRINCIPAL_INVESTIGATOR

Scottish Rite for Children

Locations

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Scottish Rite for Children

Frisco, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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STU-2019-1211

Identifier Type: -

Identifier Source: org_study_id