Balance and Falls in Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 November 2015
• Main ID: NCT02209467
• Date of registration: 04/08/2014
• Prospective Registration: No
• Primary sponsor: Örebro County Council
• Public title: Balance and Falls in Multiple Sclerosis
• Scientific title: Balance and Falls in Multiple Sclerosis: Intervention and Perceptions From Patients and Next of Kins
• Date of first enrolment: August 2014
• Target sample size: 52
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02209467
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Sweden

Contacts

• Name: Anette Forsberg, PhD
• Affiliation: Family Medicine Research Centre, Örebro County Council

• Name: Anna Carling, MSc
• Affiliation: Centre for Health Care Sciences, Örebro County Council

• Name: Ylva Nilsagård, PhD
• Affiliation: Centre for Health Care Sciences, Örebro County Council

Key inclusion & exclusion criteria

Inclusion Criteria:

- diagnosed multiple sclerosis

- Expanded Disability Scale Score of 5-6.5

- walking speed of less than 0.8 m/s as tested on a 10 meter walking test

Exclusion Criteria:

- Ongoing relapse

- Cognitive or language difficulties that prohibit participating in the intervention or
performing the outcome measures

- Change in specific MS medication during the last 30 days



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

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Other: Group balance training

Primary Outcome(s)

Change from baseline in Berg Balance Scale at 8 weeks [Time Frame: baseline, 8 weeks]

Secondary Outcome(s)

Change from baseline in 10 repetitions Sit to stand test at 15 weeks [Time Frame: baseline, 15 weeks]

Change from baseline in postural sway at 8 weeks [Time Frame: baseline, 8 weeks]

Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 15 weeks [Time Frame: baseline, 15 weeks]

Change from baseline in the 10 repetition Si to stand test at 8 weeks [Time Frame: baseline, 8 weeks]

Change from baseline on the MS Walking scale-12 at 15 weeks [Time Frame: baseline, 15 weeks]

Change from baseline in postural sway at 15 weeks [Time Frame: baseline, 15 weeks]

Change from baseline in the Trunk Impairment Scale at 15 weeks [Time Frame: baseline, 15 weeks]

Change from baseline on the Falls-Efficacy scale at 8 weeks [Time Frame: baseline, 8 weeks]

Change from baseline on the Fatigue Scale for Motor and Cognitive functions at 8 weeks [Time Frame: baseline, 8 weeks]

Change from baseline on the Timed Up and Go test at 15 weeks [Time Frame: baseline, 15 weeks]

Change from baseline in the Berg Balance scale at 15 weeks [Time Frame: baseline, 15 weeks]

Change from baseline in Trunk Impairment scale at 8 weeks [Time Frame: baseline, 8 weeks]

Change from baseline on the MS Walking Scale-12 at 8 weeks [Time Frame: baseline, 8 weeks]

Change from baseline on the Timed Up and Go test at 8 weeks [Time Frame: baseline, 8 weeks]

Change from baseline on the 2 minutes walking test at 15 weeks [Time Frame: baseline, 15 weeks]

Change from baseline on the 2 minutes walking test at 8 weeks [Time Frame: baseline, 8 weeks]

The number of falls and accidental falls [Time Frame: from baseline to 15 weeks]

Change from baseline on the10 meter walking test at 8 weeks [Time Frame: baseline, 8 weeks]

Change from baseline on the Falls Efficacy scale at 15 weeks [Time Frame: baseline, 15 weeks]

Change from baseline on the 10 meter walking test at 15 weks [Time Frame: baseline, 15 weeks]

Secondary ID(s)

Researchweb 153691

Source(s) of Monetary Support

Please refer to primary and secondary sponsors