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

Cerebellar Ataxia Clinical Trial

— EngageAtaxia  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05157802
• Other study ID #: 21-042
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 26, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Teachers College, Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Ataxia
• Cerebellar Ataxia

Intervention

Behavioral:
• Physical activity coaching
Physical activity coaching over 5 sessions

Locations

Country	Name	City	State
United States	Teachers College, Columbia University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Teachers College, Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Post-Intervention (3 months)
Primary	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.	Baseline, Post-Intervention (3 months)
Primary	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.	Baseline, Post-Intervention (3 months)
Secondary	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).	Baseline, Post-Intervention (3 months)
Secondary	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).	Baseline, Post-Intervention (3 months)
Secondary	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.	Baseline, Post-Intervention (3 months)
Secondary	Digital Biomarker of Static Posturography	Participant will perform static standing with feet together and postural sway will be recorded with a smart phone app.	Baseline, Post-Intervention (3 months)
Secondary	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.	Baseline, Post-Intervention (3 months)
Secondary	Acceptability Questionnaire	A short open-ended questionnaire to assess the acceptability of the intervention. These open-ended questions will be analyzed qualitatively.	Post-intervention (3 months)