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Trial registered on ANZCTR


Registration number
ACTRN12617000094370
Ethics application status
Approved
Date submitted
8/12/2016
Date registered
17/01/2017
Date last updated
17/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of gait disorders and the effects of a physiotherapy program in patients with Huntington's disease.
Scientific title
Evaluation of gait disorders and the effects of a physiotherapy program in patients with Huntington's disease based on the three-dimensional motion analysis system.
Secondary ID [1] 290712 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Huntington's disease 301273 0
gait disorders 301274 0
Condition category
Condition code
Physical Medicine / Rehabilitation 301035 301035 0 0
Physiotherapy
Neurological 301189 301189 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To evaluate the kinematic and spatio-temporal parameters of gait, and the effectiveness of the programmed motor improvement was used the three-dimensional motion analysis system VICON. Patients were treated in hospital 3-week motor improvement program, which consists of fifteen 90-minute individual sessions (one-on-one) conducted daily, except Saturdays and Sundays with physiotherapist. During each session the treating physiotherapist applied all the main techniques and principles of facilitation (e.g. slow approximation, timing for emphasis, bilateral reciprocal patterns) used mainly the closed kinematic chains. Each session was 90 minutes long and consisted of three parts:
- introductory part (10 min) which included: warm-up, education of a correct body awareness and
respiratory pattern,
- main part (70 min) which included: improvement of balance reactions, mat activities (rolling/prone
on elbows/bridging/side sitting/quadruped/kneeling/half-kneeling/standing), exercises in a sitting
position (rocking/scooting), gait training (weight shifting/one leg standing/walking forward,
backward, sideways/braiding),
- end part (10 min) which included relaxation techniques.
Patients attendance at session was registred.
Intervention code [1] 296605 0
Rehabilitation
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300454 0
mean spatio-temporal parameters of gait using the three-dimensional motion analysis system VICON
Timepoint [1] 300454 0
baseline, after 3 weeks of physiotherapy
Primary outcome [2] 300455 0
mean kinematic parameters of gait using the three-dimensional motion analysis system VICON
Timepoint [2] 300455 0
baseline, after 3 weeks of physiotherapy
Secondary outcome [1] 330011 0
mean tinetti gait test score
Timepoint [1] 330011 0
baseline, after 3 weeks of physiotherapy
Secondary outcome [2] 330012 0
mean time up and go test
Timepoint [2] 330012 0
baseline, after 3 weeks of physiotherapy

Eligibility
Key inclusion criteria
The inclusion criteria were as follows: mutation in the HTT gene in genetic testing, HD motor manifestation (chorea, dystonia, and/or gait disturbances) at baseline neurological examination, stable pharmacotherapy for at least one month prior to inclusion, the patient's informed consent to participate in the study.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria were: severe disability (stage 5 of the Shoulson and Fahn scale]), significant cognitive dysfunction or psychiatric symptoms (e.g. aggression, psychosis, depression) that prevented effective cooperation between the patient and physiotherapist, any orthopaedic condition (e.g. fractures, sprains) impeding movement

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8471 0
Poland
State/province [1] 8471 0
Malopolska

Funding & Sponsors
Funding source category [1] 295142 0
University
Name [1] 295142 0
The University of Physical Education in Krakow
Address [1] 295142 0
31-571 Krakow Al. Jana Pawla II 78
Country [1] 295142 0
Poland
Primary sponsor type
University
Name
The University of Physical Education in Krakow
Address
31-571 Krakow Al. Jana Pawla II 78
Country
Poland
Secondary sponsor category [1] 293961 0
None
Name [1] 293961 0
Address [1] 293961 0
Country [1] 293961 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296488 0
Bioethics Committee of the Jagiellonian University
Ethics committee address [1] 296488 0
ul. Jagiellonska 10
31-010 Cracow
Ethics committee country [1] 296488 0
Poland
Date submitted for ethics approval [1] 296488 0
26/05/2010
Approval date [1] 296488 0
24/06/2010
Ethics approval number [1] 296488 0
KBET/59B/2010

Summary
Brief summary
Physiotherapy plays a pivotal role in Huntington disease (HD) therapy in its early and moderately advanced stage. Physiotherapy procedures influence patient’s independence and physical disability. In the scientific literature there are only a few papers on rehabilitation programs in HD. The efficacy of physiotherapy has not been evaluated using unbiased, instrumental methods.
Physiotherapy techniques constitute the primary treatment approach in the management of motor control and balance disturbances irrespectively of the cause. One of physiotherapeutic techniques is Proprioceptive Neuromuscular Facilitation (PNF) which is one of widely used methods of physiotherapy e.g. in Parkinson’s disease or hemiplegia
We believe the present study enables development of a specific physiotherapy program for HD patients and understand better mechanisms of physiotherapy in HD.
Trial website
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 71042 0
Dr Elzbieta Mirek
Address 71042 0
31-571 Cracow Al. Jana Pawla II 78
The University of Physical Education Cracow
Country 71042 0
Poland
Phone 71042 0
+48695327424
Fax 71042 0
Email 71042 0
ela.mirek@wp.pl
Contact person for public queries
Name 71043 0
Dr Magdalena Filip
Address 71043 0
31-571 Cracow Al. Jana Pawla II 78
The University of Physical Education Cracow
Country 71043 0
Poland
Phone 71043 0
+48881304466
Fax 71043 0
Email 71043 0
magdalena.filip@awf.krakow.pl
Contact person for scientific queries
Name 71044 0
Dr Magdalena Filip
Address 71044 0
31-571 Cracow Al. Jana Pawla II 78
The University of Physical Education Cracow
Country 71044 0
Poland
Phone 71044 0
+48881304466
Fax 71044 0
Email 71044 0
magdalena.filip@awf.krakow.pl

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary