Physiotherapy in Hereditary Spastic Paraplegia

Phase 2

Completed

• Conditions: Hereditary Spastic Paraplegia
• Interventions: Behavioral: physiotherapy

• Registration Number: NCT03961906
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2017-03-30
• Study Completion: 2017-03-30
• Status Verified: 2019-05
• Study First Submitted: 2019-05-20
• Study First Submitted QC: 2019-05-22
• Last Update Submitted: 2019-05-22
• Study First Posted: 2019-05-23
• Last Update Posted: 2019-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tübingen physiotherapy concept	physiotherapy	Will receive our therapy concept and perform self-trainings on a regular basis.

Primary Outcome Measures

Name	Time	Method
Change in total Spastic paraplegia rating scale (SPRS) score	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

Name	Time	Method
Change in Three Minute Walk	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).

Trial Locations

Locations (1)

University Hospital Tübingen, Center for Neurology; 🇩🇪 Tübingen, Germany