Physiotherapy in Hereditary Spastic Paraplegia

Hereditary Spastic Paraplegia Clinical Trial

Official title:

Design and Validation of a Modular Physiotherapy Concept for the Treatment of Hereditary Spastic Spinal Paralysis (HSP) - a Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03961906
• Other study ID #: Physiotherapy in HSP
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2015
• Est. completion date: March 30, 2017

Study information

• Verified date: May 2019
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: March 30, 2017
• Est. primary completion date: March 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hereditary Spastic Paraplegia
• Muscle Spasticity
• Paraplegia
• Spastic Paraplegia, Hereditary

Intervention

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.

Locations

Country	Name	City	State
Germany	University Hospital Tübingen, Center for Neurology	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	12 weeks and 26 weeks