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NCT01711203 · ClinicalTrials.gov registry record · NA

The Addition of a Pilates Program for Short-Term Improvements in Patients With Spondylolysis or Spondylolisthesis

A NA study of Spondylolisthesis and Children, sponsored by Megan Donaldson PT, PhD, FAAOMPT.

Completed
Registry status
NA
Development phase
25
Enrollment target
1
Study location

NCT01711203: Completed NA study of Spondylolisthesis and Children, sponsored by Megan Donaldson PT, PhD, FAAOMPT.

NCT01711203 is a NA study of Spondylolisthesis and Children that has completed, run by Megan Donaldson PT, PhD, FAAOMPT. The registered enrollment target is 25 participants, below the 151-participant average among 18 other Spondylolisthesis trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01711203, a NA study of Spondylolisthesis and Children, has completed, sponsored by Megan Donaldson PT, PhD, FAAOMPT.

COMPLETED
Registry status
NA
Development phase
25 participants
Enrollment target
1
Study location

Study Summary

Purpose: To determine the effectiveness of an augmented Pilates program, when combined to a multimodal strengthening program, for patients under the age of 21, who have spondylolysis and/or spondylolisthesis. Significance of the topic: Spondylolysis and spondylolisthesis are often diagnosed in children and adolescents presenting with low back pain. A randomized, clinical trial, test-retest design, with a 3 week and 6 week assessment with functional performance test measures, exercise logs, adherence scale for patient and parent perception, and outcome measures (Global rating of change (GROC) and Modified Oswestry Disability Index (ODI)). This study will attempt to obtain at least 120 subjects that will be randomized into two groups: bracing and a general strengthening program vs. bracing and a Pilates/motor learning program combined with a general strengthening program. This study will begin with an initial examination and continue with treatment sessions 2x/week for 6 weeks. A follow up phone call will be conducted at 3 months after completing the 6-week protocol. The follow up phone call will be an oral conducted GROC and ODI outcome measures.

Primary Outcome

Patients will rate their overall perception of improvement since beginning treatment on a scale ranging from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). It has been recommended that scores on the GROC between ±3 and ±1 represent small changes; scores between ±4 and ±5 represent moderate changes, and scores of ±6 or ±7 large changes .

Interventions

  • OTHER Motor Control
  • OTHER General Strengthening

Study Locations (1)

Ohio

  • Akron Children's Hospital Orthopaedic and Sports Physical Therapy Center - Akron

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2012-10
Est. Completion 2014-12
Phase NA
Megan Donaldson PT, PhD, FAAOMPT

1 total trials

What the finished NCT01711203 record still lists

NCT01711203 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 151-participant average among 18 other Spondylolisthesis trials with a reported enrollment target (83% lower).

The record links to 3 conditions, with Spondylolisthesis appearing as the primary indexed condition, and to 2 interventions - of which Motor Control is the first listed.

NCT01711203 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT01711203 about?

NCT01711203 is a clinical study titled "The Addition of a Pilates Program for Short-Term Improvements in Patients With Spondylolysis or Spondylolisthesis". Purpose: To determine the effectiveness of an augmented Pilates program, when combined to a multimodal strengthening program, for patients under the age of 21, who have spondylolysis and/or spondylolisthesis. Significance of the topic: Spondylolysis and spondylolisthesis are often diagnosed in chil...

What is the current status of trial NCT01711203?

This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2012-10. Estimated completion is 2014-12.

What conditions does trial NCT01711203 study?

This clinical trial studies the following conditions: Spondylolisthesis, Children, Spondylolysis.

What interventions are being tested in trial NCT01711203?

The interventions under investigation include: Motor Control (OTHER), General Strengthening (OTHER).

Who is sponsoring clinical trial NCT01711203?

This trial is sponsored by Megan Donaldson PT, PhD, FAAOMPT, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01711203 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Spondylolisthesis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01711203's enrollment target sits among peer trials

25 18th of 18 higher than 1 of 18 other Spondylolisthesis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Spondylolisthesis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01711203, the US trial registry maintained by the National Library of Medicine. NCT01711203 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.