Physiotherapy in Hereditary Spastic Paraplegia
Primary Purpose
Hereditary Spastic Paraplegia
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Hereditary Spastic Paraplegia
Eligibility 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
Sites / Locations
- University Hospital Tübingen, Center for Neurology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Tübingen physiotherapy concept
controls
Arm Description
Will receive our therapy concept and perform self-trainings on a regular basis.
Will receive standard-care which includes their regular physiotherapy as provided by the local therapist and can include self-trainings as well.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Change in Three Minute Walk
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).
Full Information
NCT ID
NCT03961906
First Posted
May 20, 2019
Last Updated
May 22, 2019
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT03961906
Brief Title
Physiotherapy in Hereditary Spastic Paraplegia
Official Title
Design and Validation of a Modular Physiotherapy Concept for the Treatment of Hereditary Spastic Spinal Paralysis (HSP) - a Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
March 30, 2017 (Actual)
Study Completion Date
March 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Spastic Paraplegia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Masking only for baseline visit.
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tübingen physiotherapy concept
Arm Type
Active Comparator
Arm Description
Will receive our therapy concept and perform self-trainings on a regular basis.
Arm Title
controls
Arm Type
No Intervention
Arm Description
Will receive standard-care which includes their regular physiotherapy as provided by the local therapist and can include self-trainings as well.
Intervention Type
Behavioral
Intervention Name(s)
physiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in total Spastic paraplegia rating scale (SPRS) score
Description
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).
Time Frame
12 weeks and 26 weeks
Secondary Outcome Measure Information:
Title
Change in Three Minute Walk
Description
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).
Time Frame
12 weeks and 26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University Hospital Tübingen, Center for Neurology
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Available upon request
Citations:
PubMed Identifier
16894103
Citation
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.
Results Reference
background
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Physiotherapy in Hereditary Spastic Paraplegia
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