- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07934108
Impact of Community-based Boxing Exercises in Individuals With Chronic Stroke
Impact of Community-based Non-contact Boxing Exercise on Individuals With Chronic Stroke - a Pilot Study
The purpose of this study is to examine if non-contact boxing exercises improve balance, physical performance, quality of life and physical activity in adults with chronic stroke. It will also learn about the physical activity trend in adults with chronic stroke. The main research questions of the study are:
- Do community-based non-contact boxing exercises improve the balance in participants with chronic stroke?
- How is the exercise intensity of boxing exercises in individuals with chronic stroke? Researchers will test one group of participants without a comparison group.
Participants will need to complete the following tasks over 8 weeks:
- Participate in the boxing exercise program once per week for 8 weeks
- Attend two evaluation sessions: the initial and the final evaluation sessions.
- Keep a diary of their daily step counts
- Learn to assess their own physical fatigue and mental fatigue level during boxing exercise sessions.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Each participant will receive a pedometer at the end of the initial evaluation session of the study. The pedometer will be used to track their daily step count. After 8 weeks, each participant will receive a gift card with a nominal value at the final evaluation session.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Suh-Jen Lin, PT, PhD
- Telefonnummer: 2146897718
- E-post: slin@twu.edu
Studer Kontakt Backup
- Navn: Jyutika Mehta, PhD
- Telefonnummer: 214-689-6508
- E-post: jmehta@twu.edu
Studiesteder
-
-
Texas
-
Dallas, Texas, Forente stater, 75235
- Rekruttering
- The Mike A. Myers Stoke Center of Texas Woman's University - Dallas
-
Ta kontakt med:
- Jyutika Mehta, PhD
- Telefonnummer: 214-689-6508
- E-post: jmehta@twu.edu
-
Ta kontakt med:
- Suh-Jen Lin, PhD
- Telefonnummer: 214-689-7718
- E-post: slin@twu.edu
-
Hovedetterforsker:
- Suh-Jen Lin, PhD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
(1) Adults (age 18-80 years): (2) With chronic stroke (over 9 months), (3) Walk independently with or without an assistive device for a household distance (4) Montreal Cognitive Assessment (MoCA) score 23 or higher, (5) Self-report doing fine in daily activities (6) have passed the fall risk screening by the instructor (a physical therapist) of exercise program at the TWU Stroke Center to participate in the community-based group exercises.
Exclusion Criteria:
- with a hospital admission in 3 months,
- impaired cognition (MoCA score 22 or less)
- Dyspnea at rest
- with fever or self-report palpitation
- cannot walk for a household distance with an assistive device
- Currently active participation in other community exercise programs., receiving training at a physical therapy clinic, or self-exercise regularly on their own
- Inability to participate in one hour of low- to moderate-intensity exercise, even with frequent short breaks
- did not pass the fall risk screening during physical therapy examination
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Non-contact boxing exercise
non-contact group boxing exercises will be delivered at a community setting. |
The non-contact boxing exercise in delivered as a group once per week at a community-based setting for 8 weeks |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The ABC scale
Tidsramme: 8 weeks
|
The ABC scale is to assess balance confidence while performing various tasks without losing balance or feeling a state of unsteadiness. Some activities in the test include walking around the house, using stairs, reaching for objects, standing, and getting in and out of a car. |
8 weeks
|
|
PHQ-9
Tidsramme: 8 weeks
|
The PHQ-9 is a 9-item questionnaire used to screen for the severity of depression based on Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria. Each item is scored 0-3, reflecting how often symptoms occurred over the past two weeks. |
8 weeks
|
|
The Berg Balance Scale
Tidsramme: 8 weeks
|
The Berg Balance Scale is a 14-item assessment that assesses static and functional balance in adults in order to determine fall risk. It consists of standing, sitting, and sit-to-stand while unsupported. The test also includes maintaining balance while reaching and head turning. |
8 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The 10-Meter Walk Test
Tidsramme: 8 weeks
|
The 10-Meter Walk Test is a gait speed assessment that requires the participant to walk 6 meters. Participants are asked to walk as fast as possible while maintaining their balance. They will be given 2 trials and gait speed will be calculated by taking the average of the two trials. |
8 weeks
|
|
Modified Clinical Test of Sensory Interaction on Balance:
Tidsramme: 8 weeks
|
Modified Clinical Test of Sensory Interaction on Balance: This computerized test assesses an individual's postural sway and risk of falls at different conditions (30 seconds each): eyes open/firm surface, eyes closed/firm, eyes open/foam surface. eyes closed/foam surface. There are rails on both side of the platform that the participant can hold onto when needed, and two researchers will guard the participant with a gait belt. |
8 weeks
|
|
Physical activity
Tidsramme: 8 weeks
|
Participants will wear a pedometer to track their daily step count and record on the activity log (on paper) over 8 weeks. The research team will call them every week to collect their previous 7-day step count data. |
8 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Holly Hansen-Thomas, PhD, Texas Woman's University- Denton
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- IRB-FY 2026-141
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
The study protocol and statistical plan will be shared.
IPD-delingstidsramme
The IPD will be shared after completing the study (8/31/2028) for 3 years.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
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