Functional gait training as complementary treatment to botulinum toxin type A in patients with disabling dystonia due to Parkinson*s disease: a double-blind randomized controlled clinical trial.

Withdrawn

• Conditions: Dystonia; Parkinson's Disease; 10028037

• Registration Number: NL-OMON51253
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

The main inclusion criterium consists of idiopathic Parkinson*s disease and the
presence of dystonia resulting in varus tilt of the hindfoot when walking. In
addition, participants should be able to walk 100 meters and be able to follow
instructions.

Exclusion Criteria

Participants will be excluded if they:
• Have severe cognitive impairments
• Have other neurologic or orthopedic impairments that cause problems when
walking
• Are not able to walk 100 meters independently

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure of the study is the evaluation of predefined<br /><br>personal goals using the COPM. This outcome measure is measured at baseline,<br /><br>and at 8 and 16 weeks after treatment with botulinum toxin. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures include comfortable and maximum gait speed, balance<br /><br>performance (Mini-BEST), gait variability, severity of dystonia (using the<br /><br>MDS-dystonia rating scale) and time to re-injection. </p><br>