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Trial record 4 of 15 for:    Hereditary Spastic Paraplegia

Physiotherapy in Hereditary Spastic Paraplegia

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ClinicalTrials.gov Identifier: NCT03961906
Recruitment Status : Completed
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Ludger Schöls, University Hospital Tuebingen

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.


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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


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.



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).



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961906


Locations
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Germany
University Hospital Tübingen, Center for Neurology
Tübingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen

Publications:
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Responsible Party: Prof. Dr. Ludger Schöls, Principal Investigator, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03961906     History of Changes
Other Study ID Numbers: Physiotherapy in HSP
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Available upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscle Spasticity
Paraplegia
Spastic Paraplegia, Hereditary
Hereditary Sensory and Motor Neuropathy
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Paralysis
Nervous System Malformations
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Congenital Abnormalities
Genetic Diseases, Inborn