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NCT02391324 · ClinicalTrials.gov registry record · NA
Effectiveness of Robotic Gait Training and Physical Therapy for Children and Youth With Cerebral Palsy
A NA study of Cerebral Palsy, sponsored by University of Alberta.
- Recruiting
- Registry status
- NA
- Development phase
- 160
- Enrollment target
- 3
- Study locations
NCT02391324 is a NA study of Cerebral Palsy that is actively recruiting participants, run by University of Alberta. The registered enrollment target is 160 participants, below the 228-participant average among 91 other Cerebral Palsy trials with a reported enrollment target (30% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT02391324, a NA study of Cerebral Palsy, is actively recruiting participants, sponsored by University of Alberta.
- RECRUITING
- Registry status
- NA
- Development phase
- 160 participants
- Enrollment target
- 3
- Study locations
Study Summary
Robot assisted gait training is seen as a promising intervention for improving the walking abilities of children with cerebral palsy, but research to support its effectiveness compared to best practice physical therapy is lacking. This research consists of a randomized controlled trial (RCT) and a qualitative descriptive study that is linked with the RCT. The goal of the RCT is to compare: 1) a walking training program with the Lokomat® robotic device (LOK), 2) a functional physical therapy program (fPT) that includes activities to enhance balance/co-ordination/endurance and advanced motor skills conducted over 'real ground', 3) a combined Lokomat® + functional physical therapy (LOK+fPT) program, and 4) a regular maintenance therapy condition (CONT) for ambulatory children and youth with CP (aged 5- 18 years). The three intervention programs will consist of sixteen 50-minute sessions given twice weekly over 8 to 10 weeks. The primary objective of the RCT is to compare the four groups with respect to walking-related motor skills as measured by the Gross Motor Function Measure. The secondary objectives are to compare each intervention's impact on walking abilities, individualized goals, fitness, balance, physical activity levels, child's belief in ability to do physical activity, participation and quality of life. The investigators will also evaluate the extent of carryover or progress 3 months after the intervention. The qualitative part of the study will consist of interviews of children and parents after they have finished the study intervention. The information from the interviews will assist us with interpretation of the outcome results (areas of impact and amount of change) from the RCT. In particular, the interviews will 1) provide insight into their experiences with the trial interventions, 2) identify the mobility-related outcomes that are important to families and the factors that influence their preferences, and 3) explain the family values, experiences and
Conditions Studied
Interventions
- PROCEDURE Lokomat (LOK)
- PROCEDURE Gait focused physical therapy (fPT)
- PROCEDURE LOK + fPT
Study Locations (3)
Illinois
- Shirley Ryan AbilityLab - Chicago
Alberta
- University of Alberta - Edmonton
Ontario
- Holland Bloorview Kids Rehabilitation Hospital - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2016-01 |
| Est. Completion | 2025-03-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02391324
The ClinicalTrials.gov registry entry for NCT02391324 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 228-participant average among 91 other Cerebral Palsy trials with a reported enrollment target (30% lower). The listed sponsor is University of Alberta, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cerebral Palsy appearing as the primary indexed condition, and to 3 interventions - of which Lokomat (LOK) is the first listed.
NCT02391324 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Illinois, Alberta, Ontario.
Frequently Asked Questions
What is clinical trial NCT02391324 about?
NCT02391324 is a clinical study titled "Effectiveness of Robotic Gait Training and Physical Therapy for Children and Youth With Cerebral Palsy". Robot assisted gait training is seen as a promising intervention for improving the walking abilities of children with cerebral palsy, but research to support its effectiveness compared to best practice physical therapy is lacking. This research consists of a randomized controlled trial (RCT) and a q...
What is the current status of trial NCT02391324?
This trial is currently recruiting. It is a NA study. The enrollment target is 160 participants. The study started on 2016-01. Estimated completion is 2025-03-31.
What conditions does trial NCT02391324 study?
This clinical trial studies the following conditions: Cerebral Palsy.
What interventions are being tested in trial NCT02391324?
The interventions under investigation include: Lokomat (LOK) (PROCEDURE), Gait focused physical therapy (fPT) (PROCEDURE), LOK + fPT (PROCEDURE).
Who is sponsoring clinical trial NCT02391324?
This trial is sponsored by University of Alberta, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02391324 being conducted?
This trial has 3 study locations across Illinois, Alberta, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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