Physiotherapy in Hereditary Spastic Paraplegia

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Completed

CT.gov ID

NCT03961906

Collaborator

(none)

Enrollment

Location

Arms

26.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hereditary Spastic Paraplegia	Behavioral: physiotherapy	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

53 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Masking only for baseline visit.

Primary Purpose:

Treatment

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 :

Jan 1, 2015

Actual Primary Completion Date :

Mar 30, 2017

Actual Study Completion Date :

Mar 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Tübingen physiotherapy concept Will receive our therapy concept and perform self-trainings on a regular basis.	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.
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.

Arm

Intervention/Treatment

Active Comparator: Tübingen physiotherapy concept

Will receive our therapy concept and perform self-trainings on a regular basis.

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.

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.

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Tübingen, Center for Neurology	Tübingen		Germany	72076

Sponsors and Collaborators

University Hospital Tuebingen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Prof. Dr. Ludger Schöls, Principal Investigator, University Hospital Tuebingen

ClinicalTrials.gov Identifier:

NCT03961906

Other Study ID Numbers:

Physiotherapy in HSP

First Posted:

May 23, 2019

Last Update Posted:

May 23, 2019

Last Verified:

May 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Muscle Spasticity

Paraplegia

Spastic Paraplegia, Hereditary

Study Results

No Results Posted as of May 23, 2019