Feasibility and Efficacy of PRO-MAMAS

Not Applicable

• Conditions: Chronic Stroke

• Registration Number: NCT06895629
• Lead Sponsor: Tel Aviv University

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.

Study Timeline

• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-19
• Study First Posted: 2025-03-26
• Study Start: 2025-03-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21
• Primary Completion: 2026-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 30

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Satisfaction with PRO-MAMAS intervention	Post intervention (week 8)	A self-report questionnaire assessing the satisfaction with the novel intervention. The participants rate their agreement with statements relating to the intervention on a scale of 1=not at all to 5=very much.
Change in scores of the Canadian Occupational Performance Measure (COPM)	Change from pre (week 3) to post intervention (week 8)	Change in scores of performance and satisfaction of performance for therapeutic goals that the participants define as important to them. Goals will focus on maternal-role and general participation.
Change in scores of the Short Form Health Survey (SF-12)	Change from pre (week 3) to post intervention (week 8)	The SF-12 is a 12-question assessment measuring physical and mental health, including areas such as physical functioning, pain, social functioning, and emotional well-being. It generates Physical (PCS) and Mental (MCS) Component Summary scores, ranging from 0 to 100, with higher scores indicating better health.
Change in scores of the Satisfaction with Life Scale (SWLS)	Change from pre (week 3) to post intervention (week 8)	SWLS is a 5-item questionnaire that measures overall life satisfaction. Respondents rate their agreement with statements on a 7-point scale (1 = strongly disagree, 7 = strongly agree), producing a total score ranging from 5 to 35, with higher scores indicating greater life satisfaction.

Secondary Outcome Measures

Name	Time	Method
Change in the Older adults' - Meaningful Maternal-role Activities Assessment (O-MAMA)	Change from pre (week 3) to post intervention (week 8)	A self-report questionnaire, includes 37 items and measures participation of older mothers in meaningful maternal-role activities, producing two total scores: percent-Participation and percent-Non-Participation. Higher percent-Participation scores indicate more participation in meaningful maternal-role activities whereas higher percent-Non-Participation scores indicate less participation in these activities.
Change in Reintegration to Normal Living Index (RNL)	Change from pre (week 3) to post intervention (week 8)	A self-reported questionnaire for assessing participation in various contexts such as recreational activity and family roles. Scores range between 10-100, higher scores indicate more participation.
The Lawton Instrumental Activities of Daily Living (IADLq)	Change from pre (week 3) to post intervention (week 8)	A self-report questionnaire, assesses independence in tasks such as shopping. Scores range between 0-23 points, higher scores indicate more independence.
Change in Timed Up and Go (TUG)	Change from pre (week 3) to post intervention (week 8)	An assessment of mobility, measures the time (in seconds) it takes for an individual to stand up from a chair, walk 3 meters, turn, walk back, and sit down. A longer completion time indicates reduced mobility and a higher fall risk.
Change in ABILHAND	Change from pre (week 3) to post intervention (week 8)	A self-reported questionnaire that assesses manual ability in individuals with upper limb impairments. It consists of 23 items, where respondents rate the difficulty of performing daily activities using their hands. Scores are measured on a 3-point scale (0 = impossible, 1 = difficult, 2 = easy), with higher scores indicating better manual ability.
Change in Box and Blocks	Change from pre (week 3) to post intervention (week 8)	An assessment of manual dexterity and upper limb function. It involves moving as many blocks as possible from one compartment of a box to another in 60 seconds using one hand. The score is based on the total number of blocks successfully transferred, with higher scores indicating better upper limb function.

Trial Locations

Locations (1)

Tel Aviv University; 🇮🇱 Tel Aviv, Israel