Clinical trial NCT06895629: Feasibility and Efficacy of PRO-MAMAS
Official title: Feasibility and Efficacy of PRO-MAMA - a Novel Occupational Therapy Intervention for Promoting Participation, Health and Wellbeing Among Older Mothers After Stroke.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chronic Stroke
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 30
Sex: FEMALE
Minimum age (years): 70
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This experimental design will assess the feasibility \& initial effectiveness of PRO-MAMAS (promoting participation, health and wellbeing through meaningful maternal-role activities after stroke) - a novel occupational therapy intervention program to promote participation, health and wellbeing of older mothers with chronic stroke.

Assessments will be conducted at three time points: baseline, pre, post the Pro-MAMA intervention

Detailed description: This study aims to test the feasibility and initial effectiveness of PRO-MAMAS (promoting participation, health and wellbeing through meaningful maternal-role activities after stroke) in improving participation, health and wellbeing among older community dwelling mothers with chronic stroke.

PRO-MAMAS is a group intervention that aims to promote the health and wellbeing of older mothers with chronic stroke by using meaningful maternal-role activities as a motivational mean for participation. The intervention will include group discussions and practice, analysis of facilitators and barriers for participation, and home exercise. PRO-MAMAS will focus on raising awareness to meaningful maternal-role activities, identifying facilitators and barriers for participation and problem solving to enhance meaningful participation.

Eligibility criteria: Inclusion Criteria:

* Women
* Aged 70 and older
* Mothers (have at least one live and healthy child)
* With chronic stroke (at lease six months from stroke onset)
* That live at home
* That they can walk independently (with or without a walking aid)
* Without significant cognitive decline (MoCA ≥19)

Primary outcomes:
measure: Satisfaction with PRO-MAMAS intervention
timeFrame: Post intervention (week 8)
measure: Change in scores of the Canadian Occupational Performance Measure (COPM)
timeFrame: Change from pre (week 3) to post intervention (week 8)
measure: Change in scores of the Short Form Health Survey (SF-12)
timeFrame: Change from pre (week 3) to post intervention (week 8)
measure: Change in scores of the Satisfaction with Life Scale (SWLS)
timeFrame: Change from pre (week 3) to post intervention (week 8)
Secondary outcomes:
measure: Change in the Older adults' - Meaningful Maternal-role Activities Assessment (O-MAMA)
timeFrame: Change from pre (week 3) to post intervention (week 8)
measure: Change in Reintegration to Normal Living Index (RNL)
timeFrame: Change from pre (week 3) to post intervention (week 8)
measure: The Lawton Instrumental Activities of Daily Living (IADLq)
timeFrame: Change from pre (week 3) to post intervention (week 8)
measure: Change in Timed Up and Go (TUG)
timeFrame: Change from pre (week 3) to post intervention (week 8)
measure: Change in ABILHAND
timeFrame: Change from pre (week 3) to post intervention (week 8)
measure: Change in Box and Blocks
timeFrame: Change from pre (week 3) to post intervention (week 8)
Other outcomes:
measure: Demographic and stroke information questionnaire
timeFrame: baseline (week 0)
measure: The Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline (week 0)
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv University
Study officials:
References: