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Promoting Physical Activity Engagement for People With Early-stage Cerebellar Ataxia (EngageAtaxia)

Primary Purpose

Cerebellar Ataxia

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Physical activity coaching
Sponsored by
Teachers College, Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebellar Ataxia focused on measuring physical activity, physical therapy, balance training, physical activity coaching, neurodegenerative disease, rehabilitation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Neurologist confirmed diagnosis of cerebellar ataxia
  • Scale for Ataxia Rating and Assessment (SARA) score between 8-25 (total score of 40), which will capture mild to moderate stage of the disease
  • Ambulatory for indoor and outdoor mobility without assistance or assistive device
  • Successful completion of Physical Activity Readiness Questionnaire (PAR-Q) or medical clearance from primary doctor
  • Medical clearance to exercise

Exclusion Criteria:

  • Musculoskeletal injury that would prevent participation in an exercise program
  • Other neurological disease or disorder such as stroke
  • Cardiac/pulmonary conditions that would affect participants ability to participate exercise program
  • Metabolic conditions that would affect participants during an exercise program
  • Currently do moderate-vigorous exercise 5 days a week or more

Sites / Locations

  • Teachers College, Columbia University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical Activity Coaching

Arm Description

Participants will receive up to 5 individualized coaching sessions delivered via telehealth to facilitate and optimize exercise uptake. The therapist will facilitate discussion on specific and measurable goals, and will provide options for tracking their progress, such as written or web-based exercise logs or an activity monitor. The recommended exercises will be individualized to each participant but will primarily focus on increasing general physical activity (e.g. steps per day) as well as engagement in moderate intensity aerobic exercise a minimum of three times per week. Balance and strengthening exercises will also be recommended as appropriate.

Outcomes

Primary Outcome Measures

Change in Scale for Assessment and Rating for Ataxia
Clinical rating scale for severity of ataxia symptoms. This is an 8-item clinical performance based scale, which individuals are graded according to total ataxia severity. Total scores can range from 0 (no ataxia) to 40 (most severe ataxia). Scores are based on performance of the following tasks: 1) Gait, 2) Stance, 3), Sitting, 4) Speech Disturbance, 5) Finger Chase, 6) Nose-Finger Test, 7) Fast alternating hand movements, 8) Heel-shin slide. For the purpose of this study, we will be performing a modified version of the SARA, and be using the first four items of the SARA Scale (Gait, Stance, Walking, Speech) to be administered via telehealth.
Change in Cerebellar Cognitive Affective Syndrome Scale
The Cerebellar Cognitive Affective Syndrome Scale (CCAS) was developed as a bedside quick screen for Cerebellar Cognitive Affective Symptom (also referred to as Schmalmann's Syndrome). The CCAS is a 10-item scale of cognitive and neuropsychiatric tests detailing executive function, working and verbal memory, language, visuospatial function, abstract reasoning, behavior and affect. Two scores are reported; a raw score ranging from 0 (severe cognitive impairment) to 120 points (no cognitive impairment), as well as a Pass/Fail marker for each of the 10 items on the scale. 1 fail is considered as possible cerebellar cognitive affective symptom, 2 fails are considered probable, and 3 fails are considered clinically definite.
Change in Brunel Lifestyle Physical Activity Questionnaire
Evaluates both pre-planned and unplanned physical activity. Both pre-planned and unplanned physical activity subsections are separately scored through summation and average. Higher averages (closer to 5) indicate greater physical activity, whereas lower averages (closer to 0) indicate little to no physical activity in either category.

Secondary Outcome Measures

Exercise Identity Scale Exercise Identity Scale
Questions pertaining to salience of exercise identity. Scores range from 0 (no exercise identity) to 45 (high degree of exercise identity).
The Self- Efficacy for Exercise Scale
Assesses an individual's beliefs in their ability to engage with exercise. Scores range from 0 (no exercise self-efficacy) to 90 (high exercise self efficacy).
Activities Specific Balance Scale (ABC)
This assessment is a patient reported outcome evaluating the balance confidence of a participant in performing a variety of activities without losing balance or experiencing a state of unsteadiness. Participants are asked to rank their perceived balance confidence on a scale of 0% (no balance confidence) to 100% (high balance confidence). All scores are summed, and averaged for a total overall estimate of balance confidence.
Digital Biomarker of Static Posturography
Participant will perform static standing with feet together and postural sway will be recorded with a smart phone app.
Digital Biomarker of Dynamic Posturography
Participant will perform the Timed Up and Go Test (TUG) which consists of standing from a seated position, walking forward 10 feet, turning around, walking back 10 feet, and then returning to a seated position. The TUG test will be recorded with a smart phone app.
Acceptability Questionnaire
A short open-ended questionnaire to assess the acceptability of the intervention. These open-ended questions will be analyzed qualitatively.

Full Information

First Posted
November 24, 2021
Last Updated
April 7, 2022
Sponsor
Teachers College, Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT05157802
Brief Title
Promoting Physical Activity Engagement for People With Early-stage Cerebellar Ataxia
Acronym
EngageAtaxia
Official Title
Promoting Physical Activity Engagement for People With Early-stage Cerebellar Ataxia (EngageAtaxia)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 26, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teachers College, Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Engage-Ataxia will implement a physical activity coaching program for people with cerebellar ataxia at Teachers College, Columbia University. This program expands upon the current Engage program for people with Parkinson's disease (Engage-PD), an exercise coaching program for people with early stage Parkinson's disease to target individuals with early stage cerebellar ataxia. Engage-Ataxia will utilize a physical or occupational therapist to provide up to five one-on-one coaching sessions for individuals newly diagnosed with cerebellar ataxia. Therapists will work with participants to provide individualized structured support to facilitate and optimize exercise uptake as one part of comprehensive disease management. Participants will undertake two assessments three months apart, and will receive coaching interventions via Zoom healthcare platform. The primary objective of this program is to increase physical activity and exercise engagement in individuals with early stage cerebellar ataxia. This feasibility study will provide preliminary data and insight into the benefits of a remote coaching intervention for people with cerebellar ataxia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebellar Ataxia
Keywords
physical activity, physical therapy, balance training, physical activity coaching, neurodegenerative disease, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical Activity Coaching
Arm Type
Experimental
Arm Description
Participants will receive up to 5 individualized coaching sessions delivered via telehealth to facilitate and optimize exercise uptake. The therapist will facilitate discussion on specific and measurable goals, and will provide options for tracking their progress, such as written or web-based exercise logs or an activity monitor. The recommended exercises will be individualized to each participant but will primarily focus on increasing general physical activity (e.g. steps per day) as well as engagement in moderate intensity aerobic exercise a minimum of three times per week. Balance and strengthening exercises will also be recommended as appropriate.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity coaching
Intervention Description
Physical activity coaching over 5 sessions
Primary Outcome Measure Information:
Title
Change in Scale for Assessment and Rating for Ataxia
Description
Clinical rating scale for severity of ataxia symptoms. This is an 8-item clinical performance based scale, which individuals are graded according to total ataxia severity. Total scores can range from 0 (no ataxia) to 40 (most severe ataxia). Scores are based on performance of the following tasks: 1) Gait, 2) Stance, 3), Sitting, 4) Speech Disturbance, 5) Finger Chase, 6) Nose-Finger Test, 7) Fast alternating hand movements, 8) Heel-shin slide. For the purpose of this study, we will be performing a modified version of the SARA, and be using the first four items of the SARA Scale (Gait, Stance, Walking, Speech) to be administered via telehealth.
Time Frame
Baseline, Post-Intervention (3 months)
Title
Change in Cerebellar Cognitive Affective Syndrome Scale
Description
The Cerebellar Cognitive Affective Syndrome Scale (CCAS) was developed as a bedside quick screen for Cerebellar Cognitive Affective Symptom (also referred to as Schmalmann's Syndrome). The CCAS is a 10-item scale of cognitive and neuropsychiatric tests detailing executive function, working and verbal memory, language, visuospatial function, abstract reasoning, behavior and affect. Two scores are reported; a raw score ranging from 0 (severe cognitive impairment) to 120 points (no cognitive impairment), as well as a Pass/Fail marker for each of the 10 items on the scale. 1 fail is considered as possible cerebellar cognitive affective symptom, 2 fails are considered probable, and 3 fails are considered clinically definite.
Time Frame
Baseline, Post-Intervention (3 months)
Title
Change in Brunel Lifestyle Physical Activity Questionnaire
Description
Evaluates both pre-planned and unplanned physical activity. Both pre-planned and unplanned physical activity subsections are separately scored through summation and average. Higher averages (closer to 5) indicate greater physical activity, whereas lower averages (closer to 0) indicate little to no physical activity in either category.
Time Frame
Baseline, Post-Intervention (3 months)
Secondary Outcome Measure Information:
Title
Exercise Identity Scale Exercise Identity Scale
Description
Questions pertaining to salience of exercise identity. Scores range from 0 (no exercise identity) to 45 (high degree of exercise identity).
Time Frame
Baseline, Post-Intervention (3 months)
Title
The Self- Efficacy for Exercise Scale
Description
Assesses an individual's beliefs in their ability to engage with exercise. Scores range from 0 (no exercise self-efficacy) to 90 (high exercise self efficacy).
Time Frame
Baseline, Post-Intervention (3 months)
Title
Activities Specific Balance Scale (ABC)
Description
This assessment is a patient reported outcome evaluating the balance confidence of a participant in performing a variety of activities without losing balance or experiencing a state of unsteadiness. Participants are asked to rank their perceived balance confidence on a scale of 0% (no balance confidence) to 100% (high balance confidence). All scores are summed, and averaged for a total overall estimate of balance confidence.
Time Frame
Baseline, Post-Intervention (3 months)
Title
Digital Biomarker of Static Posturography
Description
Participant will perform static standing with feet together and postural sway will be recorded with a smart phone app.
Time Frame
Baseline, Post-Intervention (3 months)
Title
Digital Biomarker of Dynamic Posturography
Description
Participant will perform the Timed Up and Go Test (TUG) which consists of standing from a seated position, walking forward 10 feet, turning around, walking back 10 feet, and then returning to a seated position. The TUG test will be recorded with a smart phone app.
Time Frame
Baseline, Post-Intervention (3 months)
Title
Acceptability Questionnaire
Description
A short open-ended questionnaire to assess the acceptability of the intervention. These open-ended questions will be analyzed qualitatively.
Time Frame
Post-intervention (3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Neurologist confirmed diagnosis of cerebellar ataxia Scale for Ataxia Rating and Assessment (SARA) score between 8-25 (total score of 40), which will capture mild to moderate stage of the disease Ambulatory for indoor and outdoor mobility without assistance or assistive device Successful completion of Physical Activity Readiness Questionnaire (PAR-Q) or medical clearance from primary doctor Medical clearance to exercise Exclusion Criteria: Musculoskeletal injury that would prevent participation in an exercise program Other neurological disease or disorder such as stroke Cardiac/pulmonary conditions that would affect participants ability to participate exercise program Metabolic conditions that would affect participants during an exercise program Currently do moderate-vigorous exercise 5 days a week or more
Facility Information:
Facility Name
Teachers College, Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Promoting Physical Activity Engagement for People With Early-stage Cerebellar Ataxia

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