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

Not Applicable

• Conditions: G35; Multiple sclerosis

• Registration Number: DRKS00023960
• Lead Sponsor: Reha Zentrum Münster

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-08
• Study Completion: 2021-04-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 94

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

- 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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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