Physiotherapy in Hereditary Spastic Paraplegia

NCT ID: NCT03961906

Last Updated: 2019-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2017-03-30

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.

Conditions

Hereditary Spastic Paraplegia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tübingen physiotherapy concept

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

Group Type: ACTIVE_COMPARATOR

physiotherapy

Intervention Type: BEHAVIORAL

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.

controls

Will receive standard-care which includes their regular physiotherapy as provided by the local therapist and can include self-trainings as well.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Ludger Schöls

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Tübingen, Center for Neurology

Tübingen, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 16894103 (View on PubMed)

Other Identifiers

Physiotherapy in HSP

Identifier Type: -

Identifier Source: org_study_id