High Intensity Exercise and Improving Physical Activity Among People With Neurologic Dysfunction

NCT06945835 | Completed

• 1 other identifier: 24-10-371
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The Hawks in Motion (HIM) High Intensity Exercise program is designed to implement the American Physical Therapy Clinical Practice Guidelines and American College of Sports Medicine recommendations for exercise for people with neurologic disability. Doctor of Physical Therapy (DPT) students administer the HIM High Intensity Exercise Program. A prior study evaluated the feasibility, safety, and efficacy of the HIM High Intensity Exercise Program and found it feasible, safe, and effective for 30 people with neurologic disabilities between the ages of 8-99 years. The investigators would like to evaluate whether participation in the HIM High Intensity Exercise Program affects mobility in everyday life. Physical activity will be measured one week before program implementation and one week after to assess if the participants' mobility in everyday improved.

Conditions

Cerebral Palsy (CP); Stroke; Spinal Cord Injury; Traumatic Brain Injury; Charcot Marie Tooth Disease (CMT); Spina Bifida

Keywords

high intensity exercise; physical activity; physical disability

Outcome Measures

Primary Outcomes (9)

• Functional Gait Assessment-(FGA)

  The Functional Gait Assessment assesses postural stability during walking and assesses an individual's ability to perform multiple motor tasks while walking, with rating of performance on a scale of 0-30, with higher scores indicating better performance. The tool is reliable and valid and has an established minimally clinical important difference (MCID) for the included diagnoses: stroke, vestibular disorders, older adults and geriatric care, Parkinson's Disease, and other non-specific patient populations. For those who cannot complete this test, they will do the Berg Balance Test.

  Baseline and through study completion, an average of 8 weeks

• Canadian Occupational Performance Measure (COPM)

  The Canadian Occupational Performance Measure is a semi-structured Interview by which participants rate satisfaction and performance on patient-identified goals a scale of 1 to 10, with 1 being the lowest and 10 being the highest.

  Baseline and through study completion, an average of 8 weeks

• Berg Balance Scale- (BBS)

  The Berg Balance Scale evaluates one's ability to maintain a position and perform a specific task. The scale for scoring is based on a 5-point scale 0 being unable to complete 4 being able to complete, scores ranging 0-70. Higher scores indicate better performance. There are 14 items on the test including; sitting to standing, standing unsupported, sitting with back unsupported, standing to sitting, transfers, standing unsupported with eyes closed, standing unsupported feet together, reaching forward with outstretched arm while standing, pick up object from floor from standing, turning to look behind over both shoulders, 360 turn, toe touch unsupported, tandem unsupported, and single leg stance. The tool is reliable and valid and has an established MCID for the included diagnoses: stroke, SCI, and Parkinson's patients.

  Baseline and through study completion, an average of 8 weeks

• Activities-Specific Balance Confidence Scale (ABS)

  The Activities Balance Scale is a self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness, with 16 items. Each item is rated from 0% to 100%, with 0 indicating no confidence and 100% indicating complete confidence. All items are averaged for a total balance confidence score of 0-100%. Higher scores overall indicate greater balance confidence.

  Baseline and through study completion, an average of 8 weeks

• 10 Meter Walk Test- (10MWT)

  The 10-meter walk test is a clinical assessment used to measure short-duration walking speed in meter per seconds (m/s). It involves measuring the time it takes a participant to walk 10 meters, often with a focus on the middle 6 meters to minimize the effects of acceleration and deceleration. Average gait speed is 1.2 m/s, and can be as low as 0.3 in populations with an assistive device. A faster gait speed, or a score of less time indicates better performance. The test is frequently used to assess gait speed in various populations, including those with conditions like stroke, Parkinson's disease, and dementia.

  Baseline and through study completion, an average of 8 weeks

• 5 Times Sit to Stand: (5XSTS)

  The five time sit to stand aids in quantifying functional lower extremity strength and assessing the participant's movement strategies in performing transitional movements. The participant is instructed to sit up and down five times without using their arms as fast as they can after the clinician says "Go", and the timer stops after the patient sits down for the fifth repetition. Time varies by age group, but scores above 12 seconds may indicate fall risk. A faster speed indicates better performance. This outcome measure can be used within a variety of populations, including vestibular disorders, stroke, Parkinson's Disease, Older Adults, Multiple Sclerosis, Cerebral Palsy, and other non-specific patient populations as well. It has excellent validity and reliability, and the MCID has been established.

  Baseline and through study completion, an average of 8 weeks

• Timed 30 second repetition arm curl.

  For Individuals who are wheelchair users, and are therefore unable to stand, or who cannot safely perform standing tests a timed arm curl test will be performed. The purpose of this test is to assess upper extremity strength and endurance. The test is conducted using the dominant arm. The participant is seated on a chair with feet flat on the floor, holding a 5-pound weight in a suitcase grip (palm is facing the body) in a vertically down position by the chair (start position). The participant performs an arm curl throughout a full range of motion, gradually turning the palm up and the elbow fully bent. The arm is lowered again to the starting position with the elbow fully straightened. The participant performs as many as possible in 30 seconds. Range of number of arm cults can be from 0-30. The average number varies by age and gender, but a high number repetitions performed in 30 seconds indicates better muscle performance.

  Baseline and through study completion, an average of 8 weeks

• Timed 30 second Wheelchair Push Ups.

  Participants who use a wheelchair as primary means of locomotion will do timed 30 second wheelchair pushups. The participant demonstrates how many wheelchair pushups can be completed in 30 seconds. A push-up is when the bottom is unweighted from the seat. Range of pushup can be from 0-30. A high number repetitions performed in 30 seconds indicates better muscle performance.

  Baseline and through study completion, an average of 8 weeks

• Six minute walk test (6MWT)/6 minute push test)

  The 6MWT/push test is a sub-maximal exercise test used to assess walking or locomotion endurance and aerobic capacity. Participants will walk/push a set circuit for a total of six minutes. Distance is measured during the 6MWT or push test. Distances walked can range from 0 to 2500 meters. Longer distances indicate increased endurance and aerobic capacity.

  Baseline and through study completion, an average of 8 weeks

Secondary Outcomes (1)

• Physical Activity Monitoring

  Baseline and through study completion, an average of 8 weeks

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Participants will receive two times a week for 8 weeks one hour of individualized exercise program that is based on clinical practice guidelines for high intensity exercise.

Behavioral: Participate in high intensity exercise of at least 20 minutes in 60 minutes session of RPE greater than 6.

Interventions

Participate in high intensity exercise of at least 20 minutes in 60 minutes session of RPE greater than 6. BEHAVIORAL

Partticipants will be performing supported and unsupported walking, free weights, rowing, cycling, resistance bands, adaptive bikes and body weight exercises.

Intervention Arm

Eligibility Criteria

• Age: 8 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• physical disability that limits mobility and activities of daily living, and a neurodevelopmental disability OR neurological disability,
• age 8-99 years of age,
• understands verbal instructions,
• able to obtain medical clearance,
• able to obtain transportation to campus,
• have a parent/guardian/caregiver on site if not own legal authorized representative,
• English speaking.

You may not qualify if:

• no presence of a physical disability that impacts activities of daily living, no neurodevelopmental or neurological disability as an underlying cause,
• no person-centered goals (locomotion, fitness, transfers, and mobility),
• unstable cardiac condition,
• uncontrolled seizures,
• unstable oxygen saturation levels,
• no clearance from primary care physician for exercise,
• unable to read and understand English,
• pursuing active litigation for their physical condition.

Sponsors & Collaborators

• University of Hartford: lead

Study Sites (1)

University of Hartford

West Hartford, Connecticut, 06117, United States

Location

MeSH Terms

Conditions

Cerebral Palsy; Stroke; Spinal Cord Injuries; Brain Injuries, Traumatic; Charcot-Marie-Tooth Disease; Spinal Dysraphism; Motor Activity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries; Brain Injuries; Craniocerebral Trauma; Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Neural Tube Defects; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Pre test post test design.

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: April 25, 2025
• Study Start: February 24, 2025
• Primary Completion: May 27, 2025
• Study Completion: May 27, 2025
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)