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Completed

NCT Number: NCT04145934

A Randomized Controlled Trial of a Multicomponent Walking Aid Program for People With MS

This is a randomized controlled trial of the Assistive Device Selection, Training, and Education Program (ADSTEP). ADSTEP is a training program of six weekly one-on-one sessions with a physical therapist intended to reduce falls among people who use a hand-held walking aid, such as a cane or a walker. ADSTEP focuses on training in the use of the walking aid, and includes gait evaluation, walking aid selection and fitting, and progressive task-oriented training with the walking aid.

Participants will be randomized to receive ADSTEP or a waitlist control intervention; those in the control condition will receive National MS Society brochures on fall prevention and walking aid selection, and a letter will be sent informing their care provider that the subject reports falling. All subjects will complete an assessment visit at baseline, and follow-up assessments at about 8 weeks and about 6 months after that. Subjects will complete paper questionnaires of patient reported outcomes (PROs), a modified Functional Gait Assessment / Dynamic Gait Index, and will track fall sustained over their participation in the study using monthly paper fall calendars. At the end of study participation, all subjects in the control group will be offered the opportunity to receive ADSTEP.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A definite diagnosis of MS of any type;
  • 18 years of age or older;
  • Self-reported history of at least one fall in the previous year;
  • Ability to walk at least 25 feet with or without an assistive device;
  • Intermittent or constant unilateral or bilateral assistance required to walk;
  • No MS exacerbations for the past 30 days;
  • Willingness to complete a written daily record of falls for about 8 months.

Exclusion criteria

  • Currently receiving physical therapy, or having any plans to receive physical therapy in the upcoming 8 months (duration of study participation);
  • Serious psychiatric or medical conditions that would preclude reliable participation in the study (e.g. dementia, deafness, blindness);
  • Inability to follow directions in English.

Treatment and study plan

ADSTEP

Behavioral

ADSTEP is a training program of six weekly one-on-one sessions with a physical therapist intended to reduce falls among people who use a hand-held walking aid, such as a cane or a walker. ADSTEP focuses on training in the use of the walking aid, and includes gait evaluation, walking aid selection and fitting, and progressive task-oriented training with the walking aid.

Primary outcomes

  1. Change from Baseline in Self-Reported Falls at 8 months

    Time frame: daily for 8 months

    Paper Fall Calendars

Secondary outcomes

  1. Change from Baseline in Functional Gait Assessment / Dynamic Gait Index

    Time frame: At baseline, 8 weeks, and 8 months

    Functional Gait Assessment / Dynamic Gait Index

Other outcomes

  1. Change from Baseline in Walking Aid Satisfaction

    Time frame: At baseline, 8 weeks, and 8 months

    Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0)

  2. Change from Baseline in Physical Activity

    Time frame: At baseline, 8 weeks, and 8 months

    International Physical Activity Questionnaire (IPAQ)

  3. Change from Baseline in Walking Ability

    Time frame: At baseline, 8 weeks, and 8 months

    Multiple Sclerosis Walking Scale-12 (MSWS-12). Min/max score: 12/60, higher indicates worse outcome

  4. Change from Baseline in Quality of Life

    Time frame: At baseline, 8 weeks, and 8 months

    Multiple Sclerosis Impact Scale-29 (MSIS-29). Min/max score: 29/145, higher indicates worse outcome

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Portland VA Medical Center

Registry information

Acronym: ADSTEP

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 31, 2019
Registry last updated
Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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