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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.

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. - Gait training as complementary treatment in patients with dystonia.

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51253
Enrollment
30
Registered
2021-10-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dystonia Parkinson's Disease

Interventions

Next to the standard botulinum toxin treatment of varus tilt of the hindfoot, participants in the intervention group will receive additional daily functional gait training via home-exercises for 8 w

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The primary outcome measure of the study is the evaluation of predefined personal goals using the COPM. This outcome measure is measured at baseline, and at 8 and 16 weeks after treatment with botulinum toxin.

Secondary

MeasureTime frame
Secondary outcome measures include comfortable and maximum gait speed, balance performance (Mini-BEST), gait variability, severity of dystonia (using the MDS-dystonia rating scale) and time to re-injection.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)