Feasibility and Efficacy of PRO-MAMAS

NCT06895629 | Enrolling By Invitation

• 1 other identifier: PRO-MAMAS 0010055-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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

Conditions

Chronic Stroke

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Change in the Older adults' - Meaningful Maternal-role Activities Assessment (O-MAMA)

  Change from baseline (week 0) to post intervention (week 8)

• Change in Reintegration to Normal Living Index (RNL)

  Change from baseline (week 0) to post intervention (week 8)

• The Lawton Instrumental Activities of Daily Living (IADLq)

  Change from pre (week 0) to post intervention (week 8)

• Change in Timed Up and Go (TUG)

  Change from pre (week 3) to post intervention (week 8)

• Change in ABILHAND

  Change from pre (week 3) to post intervention (week 8)

Other Outcomes (2)

• Demographic and stroke information questionnaire

  baseline (week 0)

• The Montreal Cognitive Assessment (MoCA)

  Baseline (week 0)

Study Arms (1)

PRO-MAMAS

EXPERIMENTAL

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)

Interventions

PRO-MAMAS (Promoting participation, health and wellbeing through meaningful maternal-role activities after stroke and other chronic conditions) BEHAVIORAL

PRO-MAMAS - a novel occupational therapy intervention program to promote participation, health and wellbeing of older mothers with chronic stroke and other chronic conditions.

PRO-MAMAS

Eligibility Criteria

• Age: 70 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• Tel Aviv University: lead

Study Sites (1)

Tel Aviv University

Tel Aviv, Israel, 6997801, Israel

Location

MeSH Terms

Interventions

Health

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Debbie Rand

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: March 30, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)