NCT06108440

Brief Summary

To Compare effects of action observation and motor imagery training on upper limb function in chronic stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable stroke

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

October 25, 2023

Last Update Submit

March 12, 2024

Conditions

Keywords

StrokeUpper Extremity ParesisMotor Activity

Outcome Measures

Primary Outcomes (2)

  • Fugl-Meyer Assessment Upper Extremity (FMA UE):

    Fugl-Meyer Assessment Upper Extremity (FMA UE): FMA UE is a detailed evaluation tool that quantitatively measures motor function, balance, sensation, joint range of motion, and pain in stroke hemiplegic patients

    6 months

  • Wolf Motor Function Test (WMFT):

    Wolf Motor Function Test (WMFT): The Wolf motor function test is a tool to evaluate upper extremity motor function in hemiplegic patients. It has 17 tasks with a score range from 0-5. The inter-rater reliability of the function score is 0.88 and the inter-rated reliability of performance time is 0.97

    6 months

Study Arms (2)

action observation training group

EXPERIMENTAL

Patients in Group A will receive action observation training with conventional treatment.

Other: action observation training

motor imagery training group

ACTIVE COMPARATOR

Patients in Group B will receive motor imagery with conventional treatment.

Other: motor imagery training

Interventions

Patients in Group A will receive action observation training with conventional treatment. All participants will undergo the training for 25 minutes per session, 5 days per week for 8 weeks.

action observation training group

Patients in Group B will receive motor imagery with conventional treatment. All participants will receive interventions for twenty-five minutes per session, five times a week, for eight weeks.

motor imagery training group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed with chronic stroke by a neurologist
  • months post stroke
  • Score 1+ on modified ashworth scale
  • Having a score of 24 or higher in the Mini-Mental State Examination

You may not qualify if:

  • Patient with neurological condition other than stroke e.g. Parkinson's or multiple sclerosis
  • Presence of an attached artificial pacemaker
  • Presence of a metal implant in the brain
  • Presence of visual impairment
  • Presence of unilateral neglect in Line bisection test (25)
  • Use of antipsychotic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Fedral, 44000, Pakistan

Location

Related Publications (4)

  • Demartino AM, Rodrigues LC, Gomes RP, Michaelsen SM. Hand function and type of grasp used by chronic stroke individuals in actual environment. Top Stroke Rehabil. 2019 May;26(4):247-254. doi: 10.1080/10749357.2019.1591037. Epub 2019 Mar 23.

    PMID: 30907287BACKGROUND
  • Veldema J, Nowak DA, Gharabaghi A. Resting motor threshold in the course of hand motor recovery after stroke: a systematic review. J Neuroeng Rehabil. 2021 Nov 3;18(1):158. doi: 10.1186/s12984-021-00947-8.

    PMID: 34732203BACKGROUND
  • Kuriakose D, Xiao Z. Pathophysiology and Treatment of Stroke: Present Status and Future Perspectives. Int J Mol Sci. 2020 Oct 15;21(20):7609. doi: 10.3390/ijms21207609.

    PMID: 33076218BACKGROUND
  • Serlin Y, Shelef I, Knyazer B, Friedman A. Anatomy and physiology of the blood-brain barrier. Semin Cell Dev Biol. 2015 Feb;38:2-6. doi: 10.1016/j.semcdb.2015.01.002. Epub 2015 Feb 11.

    PMID: 25681530BACKGROUND

MeSH Terms

Conditions

StrokeParesisMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Zeest Hashmi, MSNMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be divided into Group A (n = 20) and Group B (n = 20) using a randomization through computer generated numbers program. Patients in Group A will receive action observation training with conventional treatment. All participants will undergo the training for 25 minutes per session, 5 days per week for 8 weeks. Patients in Group B will receive motor imagery with conventional treatment. All participants will receive interventions for twenty-five minutes per session, five times a week, for eight weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2023

First Posted

October 31, 2023

Study Start

August 3, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations