Long-term management of spasticity in patients with multiple sclerosis using a software application (APP) based hometraining: a prospective, randomized-controlled multicenter study

Long-term management of spasticity in patients with multiple sclerosis using a software application (APP) based hometraining: a prospective, randomized-controlled multicenter study - MS-spasticity APP

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00023960

Enrollment

Registered

2021-01-08

Start date

2017-01-02

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G35

Interventions

Group 1: Individually tailored APP-based home therapy program. An “MS-spasticity APP” was designed as described previously (Ehling et al 2016) to be run on a tablet, which is provided to study part

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: - Diagnosis of MS of any disease subtype (Polman 2010) - a 6-month history of lower limb spasticity due to MS with a mean daily score on the Numeric Rating Scale of spasticitiy (NRS) of =4 on the first three consecutive days of inpatient rehabilitation (IR) and a =20% improvement in spasticity after IR (measured as mean daily NRS score on three consecutive days during the last week of IR) - Mini Mental Score =27 - legal capacity.

Exclusion criteria

Exclusion criteria: - A score >6.5 on the Expanded Disability Status Scale - Concomitant diseases associated with spasticity - Clinical relapse within 30 days prior study inclusion or during study - Change in antispastic medical treatment - Pregnancy - Treatment with botulinum toxin of lower limbs within 90 days prior to study inclusion.

Design outcomes

Primary

Measure	Time frame
Difference in numeric rating scale spasticity between two intervention groups over study period (Delta NRS; mean of 3 days prior randomization versus mean of last week of study).	—

Secondary

Measure	Time frame
Secondary Outcome Measures: 1. modified Ashworth score 2. strength in lower limbs (motricity index) 3. timed 25-foot walk 4. 2-minute walking distance 5. spasm frequency 6. Health-related Quality of Life (SF-36) 7. Fatigue (Würzburger Fatigue Skala) 8. Anxiety and Depression (HADS-D) 9. Efficacy of inpatient rehabilitation (Phase A, oper desing; NRS spasticity; modified Ashworth score - motricity index - timed 25-foot walk- 2-minute walking distance) 10. Safety (Adverse events, numbers and reasons for study withdrawal)	—

Measure

Time frame

Secondary Outcome Measures: 1. modified Ashworth score 2. strength in lower limbs (motricity index) 3. timed 25-foot walk 4. 2-minute walking distance 5. spasm frequency 6. Health-related Quality of Life (SF-36) 7. Fatigue (Würzburger Fatigue Skala) 8. Anxiety and Depression (HADS-D) 9. Efficacy of inpatient rehabilitation (Phase A, oper desing; NRS spasticity; modified Ashworth score - motricity index - timed 25-foot walk- 2-minute walking distance) 10. Safety (Adverse events, numbers and reasons for study withdrawal)

—

Countries

Austria

Contacts

Public ContactRainer Ehling

Reha Zentrum Münster

rainer.ehling@reha-muenster.at+43 5337 20004 5113

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 13, 2026