Physiotherapy in Hereditary Spastic Paraplegia

University Hospital Tuebingen

Status and phase: Completed; Phase 2

Conditions: Hereditary Spastic Paraplegia

Treatments: Behavioral: physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03961906

Physiotherapy in HSP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 2 patient groups

Tübingen physiotherapy concept

Active Comparator group

Description:

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

Treatment:

Behavioral: physiotherapy

controls

No Intervention group

Description:

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