How Does Strength Training and Balance Training Affect Gait Function and Fatigue in Patients With Multiple Sclerosis?

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02870023
• Date of registration: 09/08/2016
• Prospective Registration: No
• Primary sponsor: University of Aarhus
• Public title: How Does Strength Training and Balance Training Affect Gait Function and Fatigue in Patients With Multiple Sclerosis?
• Scientific title: How Does Strength Training and Balance Training Affect Gait Function and Fatigue in Patients With Multiple Sclerosis?
• Date of first enrolment: June 2016
• Target sample size: 71
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02870023
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
• Phase: N/A

Countries of recruitment

Denmark

Contacts

• Name: Jacob Callesen, PT, MHSc
• Affiliation: University of Aarhus

Key inclusion & exclusion criteria

Inclusion criteria

- Diagnosed with multiple sclerosis.

- Expanded Disability Status Scale (EDSS) 2.0-6.5 and min. 2.0 in the functional system
"pyramidal function".

- Able to walk 100 m.

- Able to manage own transportation in relation to weekly training and tests.

- Six spot step test score > 8 sec. or Timed 25 foot walk > 5 sec.

Exclusion criteria

- Co-morbidity in terms of dementia and alcohol abuse.

- Attack within the last eight weeks.

- Systematic intensive rehabilitation/training within the last three months.

- Adjustment of medication within two months before inclusion. This applies only for
medication that affects gait performance and spasticity.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Other: Balance training

Other: Strength training

Primary Outcome(s)

Change in gait speed measured by "Six Spot Step Test" [Time Frame: At baseline and again after 10 weeks]

Change in gait speed measured by "Timed 25 Foot Walk" [Time Frame: At baseline and again after 10 weeks]

Secondary Outcome(s)

Fatigue [Time Frame: At baseline and after 10 weeks]

Balance - functional [Time Frame: At baseline and after 10 weeks]

Temporospatial measures [Time Frame: At baseline and after 10 weeks]

Self-evaluated gait function [Time Frame: At baseline and after 10 weeks]

Balance - static [Time Frame: At baseline and after 10 weeks]

Strength [Time Frame: At baseline and after 10 weeks]

Balance - confidence [Time Frame: At baseline and after 10 weeks]

Endurance [Time Frame: At baseline and after 10 weeks]

Secondary ID(s)

14695664

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

TrygFonden, Denmark

Fondazione Don Carlo Gnocchi Onlus

VIA University College