Active Balance and Cardio Care Intervention on Physical and Cardiovascular Health in People With Chronic Stroke

NCT06060470 | Not Yet Recruiting

• 1 other identifier: STUDY2023-1087
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Neurological impairment such as stroke is a leading cause of adult disability. Traditional rehabilitative therapies can help regain motor function and ameliorate disability. There are increasing community and other facilities offering rehabilitation in the form of conventional, recreational and alternative therapy. However, the implementation of these conventional therapy techniques in individuals with a neurological disorder like stroke is tedious, resource-intensive, and costly, often requiring transportation of patients to specialized facilities. Based on recent evidence suggesting significant benefits of repetitive, task-orientated training, investigators propose to evaluate the feasibility of an alternative therapies such as exergaming-based therapy to improve overall physical function of community-dwelling individuals with neurological impairments, compared to conventional therapeutic rehabilitation. This pilot study aims to systematically obtain data on compliance and efficacy of a randomized controlled trial. The objective of the study is to determine the safety, feasibility, compliance and efficacy of exergaming therapy to improve overall physical function of community-dwelling chronic stroke individuals.

Conditions

Chronic Stroke

Keywords

Chronic stroke; Dance-based exergaming

Outcome Measures

Primary Outcomes (3)

• Compliance to therapy

  Total time spent over the intervention duration. In virtual reality-based group a score of thirty two (number of sessions) is the maximum and a score of zero is minimum. While in the Active comparator group: control, ten is the maximum score and zero is the minimum. Higher score indicates increase compliance to therapy.

  Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)

• Voluntary balance control

  Examining maximum center of pressure (CoP) excursion on the Limits of Stability task test using Phyiosensing. Directional control, endpoint excursion, maximum excursion results will be provided in percentage. Maximum percentage being hundred and lowest being 0 percentage. Higher scores better direction, endpoint, and excursion, while lower indicates viceversa.

  Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)

• Change in Postural Stability

  Postural Stability can be defined by simultaneous control of center of mass position and velocity during slip-like perturbation relative to the rear edge of base of support (rear heel). The position normalized with the individual's foot length, and velocity by square root of gravitational acceleration and individual's body height. Greater values indicate greater stability.

  Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)

Secondary Outcomes (9)

• Fall risk

  Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)

• Real life falls

  Baseline (week 0) to post-training at home (12 months)

• Heart rate variability

  Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)

• Flow-mediated vasodilatation

  Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)

• Maximal oxygen consumption

  Baseline (week 0), Mid-training (2nd week), and Post-training at laboratory (7th week), Post-training at home (10th week)

Study Arms (2)

Virtual reality based dance group

EXPERIMENTAL

Virtual-reality based dance training - Participants received Virtual-reality based dance training for 10 weeks using the commercially available Kinect dance game (Microsoft Inc., Redmond, WA, U.S.A.) "Just Dance 3". The first six week session consisted of 5 sessions/week, next two weeks of 3 sessions/week and last two weeks of 2 sessions/week, for a total of 20 sessions. Participants played on 10 songs for the first 2 weeks, progressing to 12 songs during the 3nd and 4th weeks with an addition of 2 more songs of their choice during the last two weeks. Participants played on alternating slow- and fast-paced songs (each maximum of 4 minutes in duration) with a five minutes break after a set of one slow and fast song. The first 6 weeks are conducted in the laboratory. The next four weeks are conducted in the participants home via telerehabilitation. The four week sessions consisted of 3 sessions/week.

Behavioral: Virtual reality based dance group

Control

ACTIVE COMPARATOR

Participants in the control group will receive current standard of care: education on conventional exercise and fall prevention programs. The control and intervention groups will have the same duration of 10 weeks (1session/week), while the format of the contact (Tele) and session time of the contact will be proportional to the content delivered (30-45 minutes/session) in the control group; 80-90 minutes in the intervention group). Participants, regardless of randomization, will complete assessments and follow-ups with blinded outcome assessors.

Behavioral: Active Comparator: Control

Interventions

Virtual reality based dance group BEHAVIORAL

Participants will receive therapy using the "Just Dance" using the commercially available Kinect gaming system (Microsoft Inc, Redmond, WA, USA. Each song involves repetitive action for each dance step (at least 20 repetitions over the entire song) and visual cues on the screen (a stick figure at the bottom right) indicating the upcoming dance step. Participant's playing the game to reduce risk of exercise related adverse effects. Participants will dance on 10 songs starting from a slow-pace progressing to a medium pace (each max 5 minutes long). Participants will receive 5 minutes rest after playing on each song. This will be conducted by two physical therapists.

Also known as: Active Balance Cardio (ABC) care

Virtual reality based dance group

Active Comparator: Control BEHAVIORAL

Participants in the control group will receive current standard of care: education on conventional exercise and fall prevention programs. The control and intervention groups will have the same duration of 10 weeks (1session/week), while the format of the contact (Tele) and session time of the contact will be proportional to the content delivered (30-45 minutes/session) in the control group; 80-90 minutes in the intervention group). Participants, regardless of randomization, will complete assessments and follow-ups with blinded outcome assessors.

Also known as: Control

Control

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 90 years of age.
• Able to follow instructions provided in English.
• History of neurological impairment (Stroke) for at least 6 months prior to evaluation (self-report, confirmed by participant's physician).
• Able to stand and walk with or without assistive device or braces as part of their activities of daily living (self-report).
• Cognitive skills to actively participate (score of \< 26 on Montreal cognitive assessment indicates cognitive impairment).
• Stroke - a) Upper extremity limb function (score of at least 25 on the Fugyl Myer Upper extremity test and Muscle performance grade on deltoid, pec major and and triceps of \> or = 2/5).

You may not qualify if:

• Cognitive or communicative impairment indicated by a score of \> 26 on Montreal cognitive assessment and a score of \<25 on Mini Mental State Exam Score;
• aphasia \<71% on Mississippi Aphasia Screening Test
• \>15 on Geriatric Depression Scale.
• unhealed pressure sores,
• active or untreated infection,
• thromboembolic disease,
• severe contractures,
• active heterotrophic ossification in the lower extremities,
• lower limb fractures,
• known history of peripheral nerve injury in the lower legs,
• history of cardiovascular or pulmonary complications, or with pacemakers and history of metabolic (endocrine, hepatic) or renal dysfunction, uncontrolled seizures (Self-report).
• History of any acute and significant cardiopulmonary, musculoskeletal or systemic diagnosis in the past 6 months or history of a recent major surgery (\<6months) or hospitalization (\<3months) and on any sedative drugs.
• Partcipants unavailable for 12 weeks of participation,
• Current participation in other treatment (i.e.- Botox) or other research studies during the phase of the study.
• Pregnancy.

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Interventions

abacavir

Study Officials

• Savitha Subramaniam

  uic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Savitha Subramaniam

CONTACT

17082910471; ssubra26@uic.edu

savitha subramaniam

CONTACT

17082910471; savitharaj@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participant will be masked for the intervention group they will be assigned to. There will be masking of the outcome assessor also.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial.

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 29, 2023
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: During the entire phase of the study
• Access Criteria: University secured system

Locations

US (1)