NCT04574687

Brief Summary

This study will be conducted to evaluate the outcomes of action observation therapy on fine motor skills of affected upper limb among patients with chronic stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2020

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

9 months

First QC Date

September 25, 2020

Last Update Submit

March 29, 2021

Conditions

Chronic Stroke

Outcome Measures

Primary Outcomes (3)

  • Fugl-Meyer Assessment (FMA):

    Scoring. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully.

    2 months

  • Box and Block Test (BBT)

    Scoring The score is the number of blocks carried from one compartment to the other in one minute. Score each hand separately.

    2 months

  • Frenchay Arm Test (FAT):

    The Frenchay Arm Test (FAT) is devised for measuring the motor control in proximal joints and dexterity of the upper limb during ADL performance in patients with impairments caused by neurological conditions.Scoring and Score Interpretation Each item is scored as either pass (=1) or fail (=0). Total scores range from 0 to 5.

    2months

Study Arms (2)

Neurodevelopmental Techniques

ACTIVE COMPARATOR

Conventional treatment protocol including active and active-assissted ROM exercises. (b)Proprioceptive neuro-muscular facilitation techniques. (c)Neuromuscular Developmental Techniques.

Other: Neurodevelopmental Techniques

Action observation Therapy

EXPERIMENTAL

(a) active range of motion (AROM) exercises (10 min), (b) reaching movement or object manipulation (10 min), and (c) UE functional tasks (15 min). + Conventional treatment protocol as in group A

Other: Action observation Therapy

Interventions

Neurodevelopmental TechniquesOTHER

)Conventional treatment protocol including active and active-assissted ROM exercises. (b)Proprioceptive neuro-muscular facilitation techniques. (c)Neuromuscular Developmental Techniques.

Neurodevelopmental Techniques
Action observation TherapyOTHER

(a) active range of motion (AROM) exercises (10 min), (b) reaching movement or object manipulation (10 min), and (c) UE functional tasks (15 min). + Conventional treatment protocol as in group A

Action observation Therapy

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First-ever stroke,
  • Enrolled 6 months after the event onset with ischemia or primary hemorrhage.
  • All patients were right handed prior to stroke.

You may not qualify if:

  • Posterior circulation infarction,
  • Subarachnoid hemorrhage,
  • Severe forms of neglect and anosognosia (number of errors in Bell Barrage test≥15)
  • Impaired comprehension (Token test score ≤ 17)
  • History of endogenous depression or serious psychiatric disorders, and
  • Severe visual deficits (restricting the access to visual stimuli).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah IU

Lahore, 54000, Pakistan

Location

Related Publications (11)

  • Lee D, Roh H, Park J, Lee S, Han S. Drinking behavior training for stroke patients using action observation and practice of upper limb function. J Phys Ther Sci. 2013 May;25(5):611-4. doi: 10.1589/jpts.25.611. Epub 2013 Jun 29.

    PMID: 24259813BACKGROUND

  • Sugg K, Muller S, Winstein C, Hathorn D, Dempsey A. Does Action Observation Training With Immediate Physical Practice Improve Hemiparetic Upper-Limb Function in Chronic Stroke? Neurorehabil Neural Repair. 2015 Oct;29(9):807-17. doi: 10.1177/1545968314565512. Epub 2015 Jan 22.

    PMID: 25613984BACKGROUND

  • Franceschini M, Agosti M, Cantagallo A, Sale P, Mancuso M, Buccino G. Mirror neurons: action observation treatment as a tool in stroke rehabilitation. Eur J Phys Rehabil Med. 2010 Dec;46(4):517-23. Epub 2010 Apr 23.

    PMID: 20414184BACKGROUND

  • Sale P, Franceschini M. Action observation and mirror neuron network: a tool for motor stroke rehabilitation. Eur J Phys Rehabil Med. 2012 Jun;48(2):313-8. Epub 2012 Apr 20.

    PMID: 22522432BACKGROUND

  • Franceschini M, Ceravolo MG, Agosti M, Cavallini P, Bonassi S, Dall'Armi V, Massucci M, Schifini F, Sale P. Clinical relevance of action observation in upper-limb stroke rehabilitation: a possible role in recovery of functional dexterity. A randomized clinical trial. Neurorehabil Neural Repair. 2012 Jun;26(5):456-62. doi: 10.1177/1545968311427406. Epub 2012 Jan 10.

    PMID: 22235059BACKGROUND

  • Johansson BB. Current trends in stroke rehabilitation. A review with focus on brain plasticity. Acta Neurol Scand. 2011 Mar;123(3):147-59. doi: 10.1111/j.1600-0404.2010.01417.x. Epub 2010 Aug 19.

    PMID: 20726844BACKGROUND

  • Garrison KA, Winstein CJ, Aziz-Zadeh L. The mirror neuron system: a neural substrate for methods in stroke rehabilitation. Neurorehabil Neural Repair. 2010 Jun;24(5):404-12. doi: 10.1177/1545968309354536. Epub 2010 Mar 5.

    PMID: 20207851BACKGROUND

  • Han C, Wang Q, Meng PP, Qi MZ. Effects of intensity of arm training on hemiplegic upper extremity motor recovery in stroke patients: a randomized controlled trial. Clin Rehabil. 2013 Jan;27(1):75-81. doi: 10.1177/0269215512447223. Epub 2012 Jul 16.

    PMID: 22801472BACKGROUND

  • Eng K, Siekierka E, Pyk P, Chevrier E, Hauser Y, Cameirao M, Holper L, Hagni K, Zimmerli L, Duff A, Schuster C, Bassetti C, Verschure P, Kiper D. Interactive visuo-motor therapy system for stroke rehabilitation. Med Biol Eng Comput. 2007 Sep;45(9):901-7. doi: 10.1007/s11517-007-0239-1. Epub 2007 Aug 9.

    PMID: 17687578BACKGROUND

  • Ertelt D, Small S, Solodkin A, Dettmers C, McNamara A, Binkofski F, Buccino G. Action observation has a positive impact on rehabilitation of motor deficits after stroke. Neuroimage. 2007;36 Suppl 2:T164-73. doi: 10.1016/j.neuroimage.2007.03.043. Epub 2007 Mar 31.

    PMID: 17499164BACKGROUND

  • Borges LR, Fernandes AB, Oliveira Dos Passos J, Rego IAO, Campos TF. Action observation for upper limb rehabilitation after stroke. Cochrane Database Syst Rev. 2022 Aug 5;8(8):CD011887. doi: 10.1002/14651858.CD011887.pub3.

    PMID: 35930301DERIVED

Study Officials

  • Maryam Shabbir, Phd

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2020

First Posted

October 5, 2020

Study Start

September 15, 2019

Primary Completion

June 20, 2020

Study Completion

June 28, 2020

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)