NCT06625294

Brief Summary

Task-oriented training is an approach that will encourage active participation of the patient making treatment functional and task orientated in order to achieve the best possible recovery following injury. Neurorehabilitation studies have shown that Constrained induced movement therapy can increase both motor function and the use of the paretic arm and that these improvements parallel changes in the activation of the brain sensorimotor network. Bilateral Functional Task Training which promotes the use of the paretic limb simultaneously with the nonparetic limb. Many of our daily chores are bimanual and utilize concurrent use of both arms.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

June 20, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

October 3, 2024

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

October 1, 2024

Last Update Submit

October 2, 2024

Conditions

Keywords

Task Oriented TrainingConstraint-Induced Movement Therapy

Outcome Measures

Primary Outcomes (1)

  • Upper extremity performance

    Action Research Arm Test (ARAT) will be used for estimation of upper-limb function. This is a summated rating scale with 4 domains: Grasp, Grip, Pinch, and Gross. Scoring is based on the performance of several tasks from each domain. Each task is rated from 0 to 3, where higher scores denote less disability.

    10 weeks

Study Arms (2)

Experimental group A

EXPERIMENTAL

It includes participants receiving task oriented combined with bilateral functional task training exercises for 10 weeks treatment.

Procedure: Task -oriented training with bilateral functional task training exercises

Experimental group B

EXPERIMENTAL

This group involves participants receiving task oriented training with constrained induced movement therapy exercises for a period of 10 weeks.

Procedure: Task Oriented Training with CIMT

Interventions

Task oriented training approach with BFTT will consists of different tasks including: Hand Movements: 1. Fold a small cloth towel with both hands with initially putting the towel flat on the table and gradually folding it into a large towel roll. 2. Put a small amount of putty on patient's table and instruct to roll it with the help of rolling pin moving it back and forth using both the hands. 3. Place a jar with a removable lid on the table and instruct the patient to remove lid from the jar completely by holding the jar with either hand and remove the lid with the alternate hand. 4. Pouring water: Pour water from jug while holding the jug in unaffected hand to cup/glass that is held in affected hand and activity can be done the other way round as well. 5. Pour water from one hard plastic cup to another while alternatively involving both the hands (we must not allow deformation of the cup) 6. Plunging action with coffee maker against water resistance:Fill the coffee maker with water.

Experimental group A

• Hand Movements: 1. Sitting at a table (Wrist Extension): Affected forearm resting on table. Place cylindrical object in palm of patient's hand. Patient asked to move the hand towards the forearm (dorsiflexion) by extending the wrist - no elbow flexion allowed. 2. Sitting at a table (Radial Deviation of Wrist): Therapist should place forearm with ulnar side on table in mid-pronation / supination position. Thumb in line with forearm and wrist in extension. Fingers around cylindrical object. Patient is asked to lift hand off table. No wrist flexion or extension. Advanced Hand Activities: 1. Have the patient reach forward to pick up the top of a pen with their affected hand, bring the affected arm back to their side and put the pen cap down in front of them. 2. Place (beans), in a teacup an arm's length away on the affected side. Place another teacup an arm's length away on the intact side. Have the patient pick up one beans with their affected hand and place the beans in the cup on the

Experimental group B

Eligibility Criteria

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

You may qualify if:

  • Both genders.
  • Age range from 40 to 60 years.
  • Diagnosed Cases of Stroke.
  • MMT greater than Grade 2.
  • Wrist ROM valid for functional tasks.
  • Brunnstrom stages of recovery: Grade 4

You may not qualify if:

  • Active joint disease (rheumatoid, or any other rheumatological disease)
  • Recent history of upper limb surgery.
  • Contractures or Deformity.
  • Inability to follow-2-step commands.
  • Psychiatric diagnoses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Thrapy

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Maryam Zahid

    Foundation University Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2024

First Posted

October 3, 2024

Study Start

June 20, 2024

Primary Completion

December 1, 2024

Study Completion

December 20, 2024

Last Updated

October 3, 2024

Record last verified: 2024-09

Locations