Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05167006 |
| Other study ID # |
The University of Lahore |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 6, 2021 |
| Est. completion date |
October 15, 2022 |
Study information
| Verified date |
December 2021 |
| Source |
University of Lahore |
| Contact |
Syed Muhammad Mateen |
| Phone |
03362626270 |
| Email |
msptn02193011[@]student.uol.edu.pk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Study Design: It will be a randomized controlled trial Settings: Research will be conducted
at DHQ Teaching Hospital Dera Gazi Khan, Central Park Teaching Hospital Lahore and The
University of Lahore Teaching Hospital, Lahore.
Duration of Study: Study will be completed within 9 months after the approval of the synopsis
Sample Size: The calculated sample size is 37 in each group. i.e. n =74 (37 in each group).
By adding a 20% dropout rate the final sample size will become 88 (44 in each group)
Z1-α/2 Level of significance=80% Z1-β power of the study=80% µ1 Mean value of Box and block
test in Experimental Group=13.8224 µ2 Mean value of Box and block test in Control Group
=8.2524 δ1 SD of Box and block test in Experimental Group =12.02 δ2 SD of Box and block test
in Control Group =10.42 n Expected sample size in a group= 44
Sampling Technique: Non-probability purposive sampling technique will be used for data
collection.
Sample Selection:
Inclusion Criteria:
1. Age: 18-79 years
2. Both male and female
3. Diagnosed Stroke patients with onset of not more than 3 months.24
Exclusion Criteria:
1. 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
Equipment:
1. Chair
2. Blindfold
3. Stick
4. Cube
5. Tennis ball
6. Pen DATA COLLECTION PROCEDURE In this study, Ethical approval will be granted from the
University Institutional Review Board, University of Lahore. Study data will be
collected at DHQ Teaching Hospital Dera Gazi Khan, Central Park Teaching Hospital,
Lahore and The University of Lahore Teaching Hospital, Lahore.
Screening:
Patients will screening for inclusion/exclusion criteria. For assessing the eligibility,
assessment and screening will be performed. A consent form will be taken from all subjects,
who will be willing to participate in the study then they will be divided randomly in to two
groups.
Randomization:
Patients fulfilling the inclusion criteria then they will be divided randomly into two groups
(Group A/Control Group and Group B / Experimental Group) by using Goldfish Bowl Procedure.
Assessment:
All assessment tests will perform before and after the 12th week of treatment. After this,
baseline assessment will be performed on eligible participants. The sensory motor function
will Assess with Fugal-Meyer Assessment Upper Extremity (FMA-UE)1, 27 Dexterity will assess
with box and block test, and cognition will be assessed with Mini-Mental State Exam(MMSE).
Interventions:
Group A: 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. 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 B:
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. 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 finger
to different positions. In the start, only one joint will be moved at a time. After the
therapist will be finished repositioning the joint, the participants will inform their
perception of the joint position. Initially, the participant will differentiate between just
two positions. If they can constantly answer correctly, they will then ask to differentiate
between three, four, or five points. During this stage of training, patients will be trained,
not to try any active movement but slightly to relax and to sense the movement. For joints
with many possible planes of movement, training will be conducted separately for each plane.
For example, forward flexion and backward extension of the shoulder will be trained
separately from abduction/adduction and internal/external rotation of the shoulder. Patients
who can correctly differentiate between positions in many joints will challenge with more
complex, 'perceptive tasks'. For example, those who can sense both shoulder and elbow
positions well will be challenged to tell where their arms will be positioned on the table in
front of them. Another example of an exercise given at this stage is one in which the
therapist will passively move the patient's arm up and down while it is at rest on a tabletop
or other firm object which can be tilted to desired angles. The patient will have to sense
the tilt. Again, only two positions will have to be distinguished in the beginning. Up to
five different positions typically will be offered to the more able patients. Similar
training will be applied to the wrist, fingers, and forearms. Those patients who can
accurately distinguish these complexes, multi-joint movements can move to the next stage of
training. At this stage, the therapist placed a part of the patient's limb, typically the
fingertip, on one external object (e.g. a stick, pen, water bottle, cube, and tennis ball)
and ask the patient to actively move his or her limb over the object and try to sense the
shape, position, and size of the object. The training object will be repositioned, and
another object of a different shape or size will be offered. The patients will differentiate
between the two objects. Once they could do this, increasing numbers of objects (up to five)
will offer. Manual support from the therapist will gradually reduce until the patient could
complete the explorative task with no support.
Outcome Measures:
Sensory Motor Function:
The sensory motor function will assess with Fugal-Meyer Assessment Upper Extremity
(FMA-UE).The FMA-UE is a standardized Assessment measure of the upper extremity (Motor
function, sensation, coordination/speed, Joint range of motion, joint Pain) of the shoulder,
elbow, forearm, wrist, and fingers. A three-point ordinal scale is used to measure impairment
of volitional movement with grades ranging 0(cannot be performed), 1( partially performed),
and 2 (fully performed). Specific descriptions for performance accompany individual test
items. Subtests exist for upper extremity function (e.g Upper extremity motor function
maximum score is 66, sensation 12, passive joint motion 24, joint pain24). The complete
assessment requires 30 minutes and equipment will be used a chair, bedside table, reflex
hammer, cotton ball, pencil, a small piece of cardboard or paper small can, tennis ball,
stopwatch, and blindfold. Scoring of the classifications divide into three categories of
upper-limb motor impairment (mild, moderate, severe) based on the aggregate FMA-UE score.
Commonly used FMA-UE cutoff scores defined each category: 0 to 20 severe, 21 to 50 moderate,
and 51 to 66 mild.1, 9, 27
Cognition:
Mini-Mental State Exam (MMSE) will be used to evaluate the cognition of the patients. The
usual completion time is 8 min in cognitively unimpaired individuals, rising to 15 min in
those with cognitively impaired. It assesses different subsets of cognitive status including
orientation, registration, attention and calculation, recall and language Scoring
Interpretation of the MMSE is severe cognitive impairment (0-17), Mild cognitive impairment
(18-23), and No cognitive impairment (24-30). 38
Dexterity:
The Box and Block Test (BBT) will be used to evaluate gross manual dexterity. The setup
consists of two adjacent boxes of the same size (53.7 × 25.4 × 8.5 cm), one of them filled
with 150 blocks (2.5 cm3). Between the two boxes, there is a partition 15.2 cm in height. The
patient must move blocks one by one from one box to the other, over the partition. The number
moved in 60 seconds is the recorded score. This test is very easy to administer and takes a
very short time to complete. Scoring based on the number of blocks transferred from one
compartment to the other compartment in 60 seconds Score each hand separately. Higher scores
are indicative of better manual dexterity. During the performance of the BBT, the evaluator
should be aware of whether the client's fingertips are crossing the partition. Blocks should
be counted only when this condition is respected. Furthermore, if two blocks are transferred
at once, only one block will be counted. Blocks that fall outside the box, after trespassing
the partition, even if they do not make it to the other compartment, should be counted.
Normal value is 88 blocks transfer from one compartment to the other compartment in 60
seconds.24
