The study’s aim is to find out the efficacy of scapular and upper limb proprioceptive neuromuscular facilitation techniques along with conventional therapy on subjects with sub-acute stroke in a randomized controlled trial (RCT) with two arms of parallel superiority/equivalence on improving scapular alignment, upper limb function and gait velocity. The end point results will be compared on a marginal basis to determine effectiveness.

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To study the subjects with subacute stroke, treated with scapular and upper limb PNF techniques in addition to conventional therapy and its effect on gaining scapular alignment (measured by palpation meter), and upper limb function (measured by Fugl Meyer Assessment for Upper limb (FMA-UE)) and gait velocity (measured using 10 Meter walk test (10MWT)).

1.

To study the subjects with subacute stroke treated with scapular and upper limb proprioceptive neuromuscular facilitation techniques along with conventional therapy on improving hand grip strength using handheld dynamometer.

1.

Patients with hemiplegic subacute stroke, any gender aged between 50 and 70 years old.

1.

Patients who have heart failure symptoms, uncontrolled hypertension, or unstable angina.

Groups

Group A: Experimental group

Group B: Control group

Experimental group

After screening and randomization, the experimental group will receive scapular PNF coupled with upper limb PNF and conventional physiotherapy treatment.

PNF will be applied to the scapula and upper limb in both D1 and D2 flexion and extension patterns of the patients in side-lying and sitting position. Table 1 shows the PNF pattern of each segment. The techniques will be initiated using rhythmic initiation then progressing to combinations of isotonics, dynamic reversal, rhythmic stabilization, contract relax and hold relax techniques of PNF. These techniques will be performed for 60 minutes/day, five days/week, for six weeks. Ample amount of rest periods will be given in-between to prevent fatigue. ^{8 , 10}

Conventional physiotherapy treatment includes closed kinematic chain exercises of upper limb, upper and lower extremity range of motion exercises, stretching and strengthening exercises for upper limb, trunk and lower limb, balance & coordination, manual dexterity exercises ( e.g., grasp release), and teaching of activities of daily living (ADLs), according to the patient’s needs. ²² It will be performed for 60 minutes/day, five days/week, for six weeks. ^{16 , 23 , 24}

Control group

After screening and randomization, the control group will receive conventional physiotherapy treatment. It includes closed kinematic chain exercises of upper limb, upper and lower extremity range of motion exercises, stretching and strengthening exercises for upper limb, trunk and lower limb, balance & coordination, manual dexterity exercises ( e.g., grasp release), and teaching of ADLs, according to patient’s needs. It will be performed for 60 minutes/day, five days/week, for six weeks. ^{16 , 23 , 24}

Criteria for discontinuing allocated interventions for a given trial participant

If any patients in any of the allocated groups develop complications ( e.g., complex regional pain syndrome), their participation in the study will be discontinued. The patients will then receive appropriate care and offered outpatient rehabilitation as needed. Study participants will be retained in the trial (unless they withdraw their consent) to enable follow-up data collection and to prevent missing data.

Adherence and concomitant care

During the first consultation, the importance of following the study guidelines and adhering to the allocated group will be highlighted. Exercise adherence will be recorded as a percentage of completed exercises during the first follow up (after the six-week intervention) for both groups. Exercise adherence will be taken into consideration when performing the per-protocol analysis.

All enrolled patients will be encouraged to contact the principal investigator directly, if experiencing problems related to their allocated group intervention. The principal investigator will then fill out a standardized form at these calls. Patients can use medicines and nutritional products as needed, prescribed by their physician after the episode of stroke. To avoid study-contamination, patients will be asked to adhere to the allocated rehabilitation intervention and not to seek alternative health-care services during the course of the study. Patients will be advised to contact their general practitioner or the principal investigator as needed.

Primary outcomes

Change in palpation meter (PALM) score

A palpation meter is a dependable tool for measuring both the angles and distance of scapula. The tool is used to record the horizontal distance of scapula from spine, two measurements will be taken: the horizontal distance from the root of the spine of the scapula to the spinous process of thoracic spine(T2), and from the inferior angle of the scapula to the spinous process of thoracic spine(T7). The vertical distance of scapula will be measured from the postero-inferior angle of the acromion to spinous process of cervical spine (C7). The angles measurement will be taken from the superior angle of the two scapula and inferior angles of the two scapula. The end of one arm of the calliper will be positioned over one of the landmarks, and the end of the other arm position over another landmark. The PALM inclinometer will be level for measurement of the horizontal distance between the scapula and the thoracic spine. The inclinometer value will be used to calculate the vertical distance between the scapula and C7. A reading will be taken from both the sides, and the variances in each position will be calculated. ²⁵ When there is a bilateral disparity in scapular distance that is greater than 1.0 cm to 1.5 cm, the scapular alignment is considered inappropriate or disturbed. A positive result suggests an upward scapular rotation, while a negative result shows a downward scapular rotation. ^{26 – 28}

Change in Fugl-Meyer Assessment of Upper Extremity (FMA-UE) score

It assesses and monitors recovery in hemiplegic patients following a stroke. The FMA-UE is one of the most commonly used tools for quantifying post-stroke upper limb impairment and rehabilitation. It is a condition-specific consequence that pertains to upper limb hemiparesis in stroke patients. Scale items are assessed based on their ability to execute the item using a 3-point ordinal scale, where 0 means cannot perform, 1 means partially performs, and 2 means fully performs. A total score is derived by adding all calculated item scores with a point range of 0-126. ²⁹

Change in 10-Meter Walk Test (10MWT) score

It measures the velocity of walking in meters per second over a short period of time. To the nearest tenth of a second, the total amount of time needed to walk 6 meters (m) will be recorded. Then, 6 m will be converted to m/s by dividing it by the whole amount of time it took to ambulate (in seconds). ³⁰ Normal Walking Speed m/s - Household Ambulator <0.40 m/s; Limited Community Ambulator 0.40 to <0.80 m/s; Community Ambulator ≥0.80 m/s. ³¹

Secondary outcomes

Change in Hand Grip Strength (HGS) score (Handheld Dynamometer)

A handheld dynamometer will be used to measure HGS. The maximum value (in kg) will be obtained after the test is done three times with at least two minutes of rest in between. ³²

Change in DGI score

The DGI evaluates a participant's ability to maintain walking balance while responding to a variety of task demands in a variety of dynamic contexts. It is a useful test for those with vestibular and balance problems, as well as those who are at risk of falling. Each item is evaluated from 0 to 3, with 3 representing normal performance and 0 representing significant impairment. A DGI score of 24 is the highest possible. A total score of less than 19/24 is indicative of geriatric falls. A score of >22 signifies a safe ambulator. ³³

By using a power analysis with a 90% power and 5% Type 1 error determined for the primary variable, we determined the sample size. ¹¹

Sample size calculation formula using mean difference n 1 = n 2 = 2 Z α + Z β 2 σ 2 δ 2

Primary variable (FMA-UE)

Mean ± SD (Pre) result on FMA-UE for experimental group in stroke patients = 17.93 ± 5.22.

Mean ± SD (Post) result on FMA-UE for Experimental group in stroke patients = 25.40 ± 4.34

Difference = 7.47

Considering estimated std.dev = 7 N1 = 2 ∗ 1.96 + 1.28 2 7.47 2 / 7 2 = 18

Total samples required = 18 per Group.

Considering 10% drop out = 2

Total sample size required = 20 per group

Total sample size required (N) = 2*20 = 40

Notations: Z α = 1.96 α = TypeIerrorat 5 % Z β = 1.28 1 − β = Powerat 90 % σ = std . dev = 7

The evaluation data will be obtained from a pre-established spreadsheet with variable baseline characteristics. Research data will be placed in a secure database. Non-electronic records, such as hard copies of assessment forms, signed informed consent forms, etc., will be stored safely in the study setting. A complete backup of the data entries will be performed every month until trial completion.

Data collection and reporting will be carried out under the supervision of the principal investigators. The research reports must be carefully checked for accuracy. The Excel spreadsheet will be published at the conclusion of the study and given to the statistician for the required analysis. Checklists can be used to avoid lost data due to incorrect staff procedures.

Participant retention and completion of follow-up assessments are expected to be relatively high due to the comprehensive follow-up assessment of this trial. Patients included in this trial are invited to follow-up assessments at six weeks.

The overall results will be calculated using R studio software 4.3 version. Data for the total participants in the study will be collected and will be organized with variables per participants record for their demographic and analysis assessment. Demographic variables such as age having quantitative measurement will be presented with mean, standard deviation, medium, maximum and minimum. While those qualitative or categorical will be presented with frequency and percentage such as hand dominance, gender and side affected. All the results for inferential statistics will be tabulated and tested at 5% level of significance (P<0.05). The primary outcome variables (PALM for measuring scapular alignment, FMA-UE for measuring upper limb function and 10MWT for measuring gait velocity) and secondary outcome variables (handheld dynamometer for measuring HGS and DGI for measuring balance and gait) will be tested for the pre-post results using paired t-test. Data will be subjected to normality test using Kolmogorov–Smirnov test. In cases of failed normality, a non-parametric test will be applied and if the data are normally distributed, a parametric test will be applied. For the paired t-test, a Wilcoxon paired signed rank test will be used. An unpaired t-test will be used to find the significant difference over the mean for both primary and secondary variables between control and experimental groups. A Mann–Whitney test will be used for the unpaired t-test. Association analysis for finding significance of cofounding parameters will be evaluated by using Chi-squared test or Fisher’s exact test or by using multi-variant analysis.

We will have a data monitoring committee for maintaining and integrating the data. The whole procedure is going to be held under the supervision of clinicians and departmental committee i.e., guide, head of department, principal, and member of the research guideline cell. Every month auditing trial going to be conduct. Any deviation from the protocol will be documented and will be addressed. The final dataset will be uploaded to institutional research website and will be accessible to concerned authorities.

Principal Investigator will obtain the informed consent from the patient on a printed form with signature and given the proof of confidentiality. The study program will be elaborated to the participant and one of their relatives, and principal investigator will take personal information as a part of procedure. The consent form will include the confidentiality statement and signatures of the principal investigator, patient and two witnesses. If required to disclose some information for the study, consent will be obtained from the patient with complete assurance of his/her confidentiality.

All study-related information about the participants will be stored securely at the study site. Paper forms will in stored in locked cabinets, while electronic data will be stored on a password protected drive at the study site. Only persons involved in the trial will have access to the study-related information. Individual study information will not be released outside of the study without permission of the individual participant.

It is not expected that the allocated interventions will cause any harm to the participants. If any harm is caused, at the end of the 6-week intervention, the patients will be offered free-of-charge in- or outpatient rehabilitation as deemed clinically needed.

The principal investigator and the principal supervisor will have full access to the data set. The full-anonymized data set will be made available for the journal reviewing the manuscript.

Study status

The recruitment of participants is yet to be started.