NCT01041157

Brief Summary

The purpose of the study is to examine the effect of the botulinum toxin injection into muscle tone, strength and mobility with and without muscle exercise effect.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2009

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 31, 2009

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 31, 2009

Status Verified

December 1, 2009

Enrollment Period

1.2 years

First QC Date

December 8, 2009

Last Update Submit

December 30, 2009

Conditions

TorticollisMuscle Spasticity

Keywords

TorticollisBotulinum Toxins

Outcome Measures

Primary Outcomes (1)

  • Muscle tone in splenius capitis muscle

    five months

Secondary Outcomes (3)

  • Pain in the neck

    five months

  • Mobility in the neck

    five months

  • Neck muscle strength

    five months

Study Arms (1)

1

EXPERIMENTAL

resistance training

Other: Resistance training

Interventions

Resistance trainingOTHER

Neck muscle trainings effect on botulinum toxin efficiency

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of cervical dystonia
  • Spasticity in splenius capitis muscle
  • Regular treatment with botulinum toxin injection

You may not qualify if:

  • Don't want to take part the Trial
  • Very long distance from home to Jyväskylä Central Hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Finland Helth Care District

Jyväskylä, Finland

Location

MeSH Terms

Conditions

TorticollisMuscle Spasticity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

DystoniaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jari Ylinen, MD, PhD

    Senior physician

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 8, 2009

First Posted

December 31, 2009

Study Start

September 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2011

Last Updated

December 31, 2009

Record last verified: 2009-12

Locations

FI(1)