NCT06809504

Brief Summary

OT emphasis lies within the scope of improving daily life activities, cognitive and physical performance in order to regain the proper social role. This work assesses the impact of a 12 session structured OT intervention program for patients with SUD in IPD. Benefitting from checklists like the Montreal Cognitive Assessment (MoCA), the Barthel Index, the Lawton-Brody IADLs scale, it substantiates attaining enhancements in expressive cognitive functions, ADLs, and IADLs to understand how selected OT intervention modalities can enhance functional capabilities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
Last Updated

February 5, 2025

Status Verified

February 1, 2025

Enrollment Period

7 months

First QC Date

January 28, 2025

Last Update Submit

February 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Montreal Cognitive Assessment (MoCA):

    The MoCA offers assessment of many cognitive aspects, it presents assessments for attention, memory, language, visual construction, executive functions, and orientation.

    baseline and after 12 weeks of intervention

Study Arms (1)

Experimental Group

EXPERIMENTAL

Exercise based intervention was given for 12 sessions over 4 weeks, 45-minute sessions

Behavioral: Exercise based intervention

Interventions

12 sessions over 4 weeks, 45-minute sessions divided into: o 15 minutes for physical exercises

Experimental Group

Eligibility Criteria

AgeUp to 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Substance abused disorder
  • Admitted in rehabilitation center

You may not qualify if:

  • Severe cognitive impairment
  • Physical disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FMRL

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 12 sessions over 4 weeks, 45-minute sessions divided into: * 15 minutes for physical exercises * 15 minutes for psychoeducation * 15 minutes for cognitive tasks and routine planning
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Mr

Study Record Dates

First Submitted

January 28, 2025

First Posted

February 5, 2025

Study Start

April 14, 2024

Primary Completion

November 12, 2024

Study Completion

December 20, 2024

Last Updated

February 5, 2025

Record last verified: 2025-02

Locations