Physiotherapy in Hereditary Spastic Paraplegia
Design and Validation of a Modular Physiotherapy Concept for the Treatment of Hereditary Spastic Spinal Paralysis (HSP) - a Randomized Study
1 other identifier
interventional
53
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2017
CompletedFirst Submitted
Initial submission to the registry
May 20, 2019
CompletedFirst Posted
Study publicly available on registry
May 23, 2019
CompletedMay 23, 2019
May 1, 2019
2.2 years
May 20, 2019
May 22, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in total Spastic paraplegia rating scale (SPRS) score
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).
12 weeks and 26 weeks
Secondary Outcomes (1)
Change in Three Minute Walk
12 weeks and 26 weeks
Study Arms (2)
Tübingen physiotherapy concept
ACTIVE COMPARATORWill receive our therapy concept and perform self-trainings on a regular basis.
controls
NO INTERVENTIONWill receive standard-care which includes their regular physiotherapy as provided by the local therapist and can include self-trainings as well.
Interventions
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.
Eligibility Criteria
You may qualify if:
- clinical diagnosis of hereditary spastic paraplegia
- manifest spastic gait disturbance
- remaining walking ability of at least 100m in three minutes,
- no functional electronic stimulation during the study period.
You may not qualify if:
- see above
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Tübingen, Center for Neurology
Tübingen, 72076, Germany
Related Publications (1)
Schule R, Holland-Letz T, Klimpe S, Kassubek J, Klopstock T, Mall V, Otto S, Winner B, Schols L. The Spastic Paraplegia Rating Scale (SPRS): a reliable and valid measure of disease severity. Neurology. 2006 Aug 8;67(3):430-4. doi: 10.1212/01.wnl.0000228242.53336.90.
PMID: 16894103BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Masking only for baseline visit.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 20, 2019
First Posted
May 23, 2019
Study Start
January 1, 2015
Primary Completion
March 30, 2017
Study Completion
March 30, 2017
Last Updated
May 23, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share
Available upon request