NCT05084820

Brief Summary

To determine the effects of action observation treatment on motor functions in upper limb of patients with chronic stroke

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Oct 2020

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

October 15, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
Last Updated

October 20, 2021

Status Verified

October 1, 2021

Enrollment Period

9 months

First QC Date

October 7, 2021

Last Update Submit

October 19, 2021

Conditions

Keywords

strokeaction observation treatment

Outcome Measures

Primary Outcomes (2)

  • modified barthal index

    The Modified Barthel Index score was used for practical evaluation in activities of daily living. The MBI comprises of 10 items, 6 out of 10 items scored from 0-2 points, 2 items scored from 0-3 points and other 2 items scored from 0-3 points, giving a highest total score of 20 points.

    40 minutes

  • Fugl-Meyer Assessment test

    Fugl-Meyer Assessment test for Upper extermity.to assess level of motor impairment and its recovery after treatment. The FMA-UE comprises of 7 times.

    40 minutes

Study Arms (2)

Action observation treatment

EXPERIMENTAL

Action observation treatment

Combination Product: Action observation treatment

conventional treatment

ACTIVE COMPARATOR

conventional treatment

Combination Product: conventional treatment

Interventions

Action observation treatmentCOMBINATION_PRODUCT

Participants will watch 5 videos of motor tasks; each video is of 30 sec and watch for 4 times (i.e. for 2 minutes). Then patient will execute the motor act, soon after the observation with an affected limb for 2 minutes, with total rest time of 5 minutes for this treatment. Conventional treatment of muscle stretching, strengthening and ROM exercises will be given for 15 minutes including rest. Total treatment time is 40 minutes.

Action observation treatment
conventional treatmentCOMBINATION_PRODUCT

conventional treatment of 40 minutes in total will be performed including Stretching (for 8-10 sec with set of 5 repetitions/ session on each side for 3 minutes total with rest), strengthening (weighted bicep curls, side arm raise and open arm movement exercises with set of 5 repetitions/ session for 9 minutes total with rest), Range of motion exercises active and passive with set of 5 repetitions/ session for 3 minutes total with rest and gripping,reaching, grasping exercises (on each side for total 25 minutes including rest) with assistance of physiotherapist

conventional treatment

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic Stroke patients (with more than 6 months- 4 years) illness
  • Patients that were able to communicate and comprehend oral instructions
  • Patients with Mini Mental State Examination (MMSE) score more than 24

You may not qualify if:

  • Patients having psychiatric histories.
  • Visual and hearing impaired patients
  • Patients with speech impairment
  • Patients with arthritic deformities in upper limb (with or without using assistive device)
  • Patients with diagnosed mental illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah international university

Islamabad, Fedral, 44000, Pakistan

Location

Related Publications (4)

  • Mao H, Li Y, Tang L, Chen Y, Ni J, Liu L, Shan C. Effects of mirror neuron system-based training on rehabilitation of stroke patients. Brain Behav. 2020 Aug;10(8):e01729. doi: 10.1002/brb3.1729. Epub 2020 Jul 1.

    PMID: 32608554BACKGROUND
  • Keller J, Stetkarova I, Macri V, Kuhn S, Petioky J, Gualeni S, Simmons capital ES, CyrillicD, Arthanat S, Zilber P. Virtual reality-based treatment for regaining upper extremity function induces cortex grey matter changes in persons with acquired brain injury. J Neuroeng Rehabil. 2020 Sep 12;17(1):127. doi: 10.1186/s12984-020-00754-7.

    PMID: 32919473BACKGROUND
  • Keci A, Tani K, Xhema J. Role of Rehabilitation in Neural Plasticity. Open Access Maced J Med Sci. 2019 May 14;7(9):1540-1547. doi: 10.3889/oamjms.2019.295. eCollection 2019 May 15.

    PMID: 31198470BACKGROUND
  • Habibi-Koolaee M, Shahmoradi L, Niakan Kalhori SR, Ghannadan H, Younesi E. Prevalence of Stroke Risk Factors and Their Distribution Based on Stroke Subtypes in Gorgan: A Retrospective Hospital-Based Study-2015-2016. Neurol Res Int. 2018 Jul 26;2018:2709654. doi: 10.1155/2018/2709654. eCollection 2018.

    PMID: 30147952BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • zeest hashmi, MS NMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: each participant will be requested to draw either number one or two from a box.number one refers to group A and number two refers to group B. Group A patients will receive conventional treatment of 40 minutes in total. group B is experimental group , patients will watch videos of 5 common motor tasks that implicit the usage of items to be used for action observation treatment.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2021

First Posted

October 20, 2021

Study Start

October 15, 2020

Primary Completion

July 15, 2021

Study Completion

August 15, 2021

Last Updated

October 20, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations