NCT05167006

Brief Summary

Null Hypothesis (HO) There is no difference between the effects of Perfetti's Method versus routine physical therapy on cognition, dexterity, and sensory motor function of the upper extremity in stroke patients. Alternate Hypothesis (HA) There is a difference between the effects of Perfetti's Method versus routine physical therapy on cognition, dexterity, and sensory motor function of the upper extremity in stroke patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

December 6, 2021

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2022

Completed
Last Updated

January 13, 2022

Status Verified

December 1, 2021

Enrollment Period

9 months

First QC Date

December 20, 2021

Last Update Submit

December 23, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Sensory Motor Function:

    The sensory motor function will assess with Fugal-Meyer Assessment Upper Extremity (FMA-UE).

    12 week

  • Cognition:

    Mini-Mental State Exam (MMSE) will be used to evaluate the cognition of the patients.

    12 week

  • Dexterity:

    The Box and Block Test (BBT) will be used to evaluate gross manual dexterity.

    12 week

Study Arms (2)

Group A:

EXPERIMENTAL

Participants will be treated with routine physical therapy for 20 minutes, five days a week for 12th weeks. Each participant will receive his/her arms training therapy. Only one participant per therapist, with or without caregiver observation.

Other: routine physical therapy

Group B

ACTIVE COMPARATOR

The participants will be treated with Perfetti's method and routine physical therapy for 35 minutes, five times a week for 12th weeks. Each participant will receive his/her arms training therapy.

Other: Perfetti's method

Interventions

Each participant will receive his/her arms training therapy. Only one participant per therapist, with or without caregiver observation. Consisting of many purposeful kinesthetic activities such as Graded pinch exercise, Bimanual placing cone, Arm bicycling, Shoulder curved arch, Double-curved arch, Block-stacking, Skateboard-supported arm sliding exercises on a tabletop, Putty kneading, Pegboard exercise, Picking up a ball and putting it into a basket, Plastic cone stacking. Therapists can offer passive, active-assistive, or active training, as deemed appropriate to the patient's ability

Group A:

. Only one participant per therapist, with or without caregiver observation. Participant will be blindfolded during the exercises and asked to focus on sensing the position of the limb. The therapist will passively move the shoulder, elbow, wrist, or fing

Group B

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18-79 years
  • Both male and female
  • Diagnosed Stroke patients with onset of not more than 3 months.24

You may not qualify if:

  • \. Other Neurological disorder 2. Orthopedic disease impairing arm function 3. Fracture of the Arm 4. Frozen shoulder 5. No previous history of Stroke 6. Re stroke during the study.24

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Syed Muhammad Mateen

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ayesha Jamil

    University of Lahore

    STUDY CHAIR
  • Umair Ahmad

    University of Lahore

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 20, 2021

First Posted

December 22, 2021

Study Start

December 6, 2021

Primary Completion

September 15, 2022

Study Completion

October 15, 2022

Last Updated

January 13, 2022

Record last verified: 2021-12

Locations