Feasibility and Efficacy of PRO-MAMAS (PRO-MAMAS)

Feasibility and Efficacy of PRO-MAMA - a Novel Occupational Therapy Intervention for Promoting Participation, Health and Wellbeing Among Older Mothers After Stroke and Other Chronic Conditions.

This experimental design will assess the feasibility & initial effectiveness of PRO-MAMAS (promoting participation, health and wellbeing through meaningful maternal-role activities after stroke and other chronic conditions) - 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

Study Overview

• Status: Enrolling by invitation
• Conditions: Chronic Stroke
• Intervention / Treatment: Behavioral: PRO-MAMAS (Promoting participation, health and wellbeing through meaningful maternal-role activities after stroke and other chronic conditions)

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 and other chronic conditions) in improving participation, health and wellbeing among older community dwelling mothers with chronic stroke and other chronic conditions.

PRO-MAMAS is a group intervention that aims to promote the health and wellbeing of older mothers with chronic stroke and other chronic conditions 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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Israel
    • Tel Aviv, Israel, Israel, 6997801
      • Tel Aviv University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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) or other age-related chronic conditions
• That live at home
• That they can walk independently (with or without a walking aid)
• Without significant cognitive decline (MoCA ≥19)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRO-MAMAS; All participants will receive PRO-MAMAS - a novel occupational therapy intervention. PRO-MAMAS will include 8 sessions (2 sessions per week for 4 weeks). PRO-MAMAS will include small group of 5-8 participants, so approximately 4 rounds of PRO-MAMAS will be needed to reach 30 participants	Behavioral: PRO-MAMAS (Promoting participation, health and wellbeing through meaningful maternal-role activities after stroke and other chronic conditions); PRO-MAMAS - a novel occupational therapy intervention program to promote participation, health and wellbeing of older mothers with chronic stroke and other chronic conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with PRO-MAMAS intervention	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.	Post intervention (week 8)
Change in scores of the Canadian Occupational Performance Measure (COPM)	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 from pre (week 3) to post intervention (week 8)
Change in scores of the Short Form Health Survey (SF-12)	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 from pre (week 3) to post intervention (week 8)
Change in scores of the Satisfaction with Life Scale (SWLS)	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.	Change from pre (week 3) to post intervention (week 8)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Timed Up and Go (TUG)	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 from pre (week 3) to post intervention (week 8)
Change in ABILHAND	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 from pre (week 3) to post intervention (week 8)
Change in Box and Blocks	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.	Change from pre (week 3) to post intervention (week 8)
Change in the Older adults' - Meaningful Maternal-role Activities Assessment (O-MAMA)	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 from baseline (week 0) to post intervention (week 8)
Change in Reintegration to Normal Living Index (RNL)	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.	Change from baseline (week 0) to post intervention (week 8)
The Lawton Instrumental Activities of Daily Living (IADLq)	A self-report questionnaire, assesses independence in tasks such as shopping. Scores range between 0-23 points, higher scores indicate more independence.	Change from pre (week 0) to post intervention (week 8)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic and stroke information questionnaire	To describe the participants	baseline (week 0)
The Montreal Cognitive Assessment (MoCA)	To describe the participants' cognitive status. Scores range between 0-30, a score of 26 or above is considered in the normal range.	Baseline (week 0)

Collaborators and Investigators

• Sponsor: Tel Aviv University

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Population Characteristics; Health
• Other Study ID Numbers: PRO-MAMAS 0010055-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No