Effects of Perfetti's Method on Cognition, Dexterity and Sensory Motor Function of the Upper Extremity in Stroke Patients
1 other identifier
interventional
88
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2021
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
December 20, 2021
CompletedFirst Posted
Study publicly available on registry
December 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2022
CompletedJanuary 13, 2022
December 1, 2021
9 months
December 20, 2021
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:
EXPERIMENTALParticipants 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.
Group B
ACTIVE COMPARATORThe 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.
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
. 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
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ayesha Jamil
University of Lahore
- STUDY DIRECTOR
Umair Ahmad
University of Lahore
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