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
|Condition or disease||Intervention/treatment||Phase|
|Hereditary Spastic Paraplegia||Behavioral: physiotherapy||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Masking only for baseline visit.|
|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|
Active Comparator: Tübingen physiotherapy concept
Will receive our therapy concept and perform self-trainings on a regular basis.
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.
- 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).
- 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).
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
|University Hospital Tübingen, Center for Neurology|
|Tübingen, Germany, 72076|