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出境医 / 临床实验 / Physiotherapy in Hereditary Spastic Paraplegia

Physiotherapy in Hereditary Spastic Paraplegia

Study Description
Brief Summary:
Goal of this study is to develop and evaluate a physiotherapy concept that is focused on bilateral leg spasticity and aims to reduce spastic gait disturbance and to improve mobility in patients suffering from HSP.

Condition or disease Intervention/treatment Phase
Hereditary Spastic Paraplegia Behavioral: physiotherapy Phase 2

Detailed Description:

This is a randomized single-center parallel study with a control group design. A blinded block randomization in groups of four was performed in equal parts toward the treatment (TPC) or the control (regular standard-of-care) group using randomization.com. Group assignment was kept in a closed envelope which was opened by the participant at the end of the baseline visit. Therefore both, the movement disorder specialist as well as the physiotherapist, were blinded to the randomization result for the baseline assessment up to the beginning of the first physiotherapy training session.

Therapeutic effects were evaluated at follow-up visits after 12 weeks (first visit, short-term effect) and after 26 weeks (second visit, long-term effect) comparing standard-of care with the TPC. Clinical evaluation is stated in detail below. Primary outcome assessment of this study was the change between baseline and follow-up assessment in treatment to control group in the spastic paraplegia rating scale (SPRS) score as a validated measure of disease severity (see Reference). Secondary outcome assessment was the change in walking distance in the Three-Minute-Walking test (3MW). Further exploratory outcome assessments were evaluated as effect sizes as specified below.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Masking only for baseline visit.
Primary Purpose: Treatment
Official Title: Design and Validation of a Modular Physiotherapy Concept for the Treatment of Hereditary Spastic Spinal Paralysis (HSP) - a Randomized Study
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : March 30, 2017
Actual Study Completion Date : March 30, 2017
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Tübingen physiotherapy concept
Will receive our therapy concept and perform self-trainings on a regular basis.
Behavioral: physiotherapy
Will receive two trainings. First training in week one after baseline assessment for three consecutive days 60 min twice daily by trained physiotherapists and in week three further two days with 60min once daily.

No Intervention: controls
Will receive standard-care which includes their regular physiotherapy as provided by the local therapist and can include self-trainings as well.
Outcome Measures
Primary Outcome Measures :
  1. Change in total Spastic paraplegia rating scale (SPRS) score [ Time Frame: 12 weeks and 26 weeks ]
    Change in the total SPRS score (see references for publication) (range 0-52 points, higher points indicated stronger disease severity) will be evaluated at two timepoints compared to baseline (12 weeks as short-term measure and 26 weeks as long-term measure).


Secondary Outcome Measures :
  1. Change in Three Minute Walk [ Time Frame: 12 weeks and 26 weeks ]
    Change in walking distance within three minutes will be assessed two timepoints compared to baseline (12 weeks as short-term measure and 26 weeks as long-term measure).


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of hereditary spastic paraplegia
  • manifest spastic gait disturbance
  • remaining walking ability of at least 100m in three minutes,
  • no botulinum toxin treatment during the entire study and three months prior to study inclusion
  • no functional electronic stimulation during the study period.

Exclusion Criteria:

  • see above
Contacts and Locations

Locations
Layout table for location information
Germany
University Hospital Tübingen, Center for Neurology
Tübingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Tracking Information
First Submitted Date  ICMJE May 20, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date May 23, 2019
Actual Study Start Date  ICMJE January 1, 2015
Actual Primary Completion Date March 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
Change in total Spastic paraplegia rating scale (SPRS) score [ Time Frame: 12 weeks and 26 weeks ]
Change in the total SPRS score (see references for publication) (range 0-52 points, higher points indicated stronger disease severity) will be evaluated at two timepoints compared to baseline (12 weeks as short-term measure and 26 weeks as long-term measure).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
Change in Three Minute Walk [ Time Frame: 12 weeks and 26 weeks ]
Change in walking distance within three minutes will be assessed two timepoints compared to baseline (12 weeks as short-term measure and 26 weeks as long-term measure).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physiotherapy in Hereditary Spastic Paraplegia
Official Title  ICMJE Design and Validation of a Modular Physiotherapy Concept for the Treatment of Hereditary Spastic Spinal Paralysis (HSP) - a Randomized Study
Brief Summary Goal of this study is to develop and evaluate a physiotherapy concept that is focused on bilateral leg spasticity and aims to reduce spastic gait disturbance and to improve mobility in patients suffering from HSP.
Detailed Description

This is a randomized single-center parallel study with a control group design. A blinded block randomization in groups of four was performed in equal parts toward the treatment (TPC) or the control (regular standard-of-care) group using randomization.com. Group assignment was kept in a closed envelope which was opened by the participant at the end of the baseline visit. Therefore both, the movement disorder specialist as well as the physiotherapist, were blinded to the randomization result for the baseline assessment up to the beginning of the first physiotherapy training session.

Therapeutic effects were evaluated at follow-up visits after 12 weeks (first visit, short-term effect) and after 26 weeks (second visit, long-term effect) comparing standard-of care with the TPC. Clinical evaluation is stated in detail below. Primary outcome assessment of this study was the change between baseline and follow-up assessment in treatment to control group in the spastic paraplegia rating scale (SPRS) score as a validated measure of disease severity (see Reference). Secondary outcome assessment was the change in walking distance in the Three-Minute-Walking test (3MW). Further exploratory outcome assessments were evaluated as effect sizes as specified below.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Masking only for baseline visit.
Primary Purpose: Treatment
Condition  ICMJE Hereditary Spastic Paraplegia
Intervention  ICMJE Behavioral: physiotherapy
Will receive two trainings. First training in week one after baseline assessment for three consecutive days 60 min twice daily by trained physiotherapists and in week three further two days with 60min once daily.
Study Arms  ICMJE
  • Active Comparator: Tübingen physiotherapy concept
    Will receive our therapy concept and perform self-trainings on a regular basis.
    Intervention: Behavioral: physiotherapy
  • No Intervention: controls
    Will receive standard-care which includes their regular physiotherapy as provided by the local therapist and can include self-trainings as well.
Publications * Schüle R, Holland-Letz T, Klimpe S, Kassubek J, Klopstock T, Mall V, Otto S, Winner B, Schöls L. The Spastic Paraplegia Rating Scale (SPRS): a reliable and valid measure of disease severity. Neurology. 2006 Aug 8;67(3):430-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2019)
53
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 30, 2017
Actual Primary Completion Date March 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • clinical diagnosis of hereditary spastic paraplegia
  • manifest spastic gait disturbance
  • remaining walking ability of at least 100m in three minutes,
  • no botulinum toxin treatment during the entire study and three months prior to study inclusion
  • no functional electronic stimulation during the study period.

Exclusion Criteria:

  • see above
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03961906
Other Study ID Numbers  ICMJE Physiotherapy in HSP
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Available upon request
Responsible Party Prof. Dr. Ludger Schöls, University Hospital Tuebingen
Study Sponsor  ICMJE University Hospital Tuebingen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital Tuebingen
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP