Protocol summary

Study aim
The effect of adding kinetic chain exercises to the routine rehabilitation protocol (ASSET) on the pattern of muscle activity and kinematics of the shoulder joint, pain, functional abilities and quality of life of people after shoulder rotator cuff tendon repair surgery
Design
Clinical trial with test and control group, with parallel groups, single-blind, randomized, on 28 patients in which sealed envelopes were used for randomization
Settings and conduct
Immediately after the surgery, the participants undergo passive phase treatment for 6 weeks, same for everyone After 6 weeks, they are divided into two test and control groups by randomization method and in a blind way. The first same assessment session for both groups is done, which includes assessment of SHR, EMG and AROM of shoulder elevation by motion analysis system, measurement of PROM of shoulder by goniometer, pain assessment by VAS, DASH and SF-36 quality of life questionnaire are filled Then both groups enter the second phase of 4 weeks treatment, which is based on ASSET protocol The test group, in addition to the mentioned treatment received the kinetic chain exercises program as therapeutic intervention Finally, the second assessment session is conducted in both groups, similar to the first session
Participants/Inclusion and exclusion criteria
Patients with partial supraspinatus tendon tear underwent arthroscopic tendon repair surgery
Intervention groups
The control group is treated with routine rehabilitation protocol (ASSET) The test group, in addition to the treatment of the control group, also performs kinetic chain exercises
Main outcome variables
scapulohumeral rhythm in the sagittal plane; scapulohumeral rhythm in the scapular plane; Linear envelop; RMS; start time of muscle activity; time of the maximum range of muscle activity; maximum muscle activity; contraction termination time; functional activity; quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240409061455N1
Registration date: 2024-04-17, 1403/01/29
Registration timing: prospective

Last update: 2024-04-17, 1403/01/29
Update count: 0
Registration date
2024-04-17, 1403/01/29
Registrant information
Name
Nazanin Fatemeh Afshari
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 5231
Email address
afshary@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-07-21, 1403/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Adding Kinetic Chain Exercises to Routine Rehabilitation Protocol on the Muscle Activation Pattern, Shoulder Kinematics, Pain, Functional Abilities and Quality of Life after Rotator Cuff Tendons Repair
Public title
The effect of kinetic chain exercises on the treatment of patients after rotator cuff tendons repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Degenerative partial tear of the supraspinatus tendon (medium or tear size 1-3 cm) Patients who are candidates for surgery according to AAOS guideline criteria and have undergone surgery Patients who had symptoms for a maximum of one year before surgery Patients who have undergone arthroscopic tendon repair surgery by the same surgeon with the same surgical technique The intensity of the patient's pain when entering the active movement stage should be 2 to 5 based on the visual analog scale BMI below 30 No history of professional sports or continuous sports Age range 40 to 65 years
Exclusion criteria:
Large and massive supraspinatus tendon tear Traumatic tear Tendon re-rupture and repair Associated injuries Frozen shoulder Arthritis of the glenohumeral joint History of surgery in the involved shoulder Problems of the lower limbs, pelvis and spine that interfere with doing exercises Diabetes Smoking addiction
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Randomized
Randomization description
People are divided into two test and control groups by randomization method with sealed envelopes. In this way, the control and test words (14 each) are written on the cards according to the number of the studied sample and each one is put in an envelope and the envelopes are sealed. Then, each patient who enters the study randomly chooses one envelope from the total envelopes and is placed in one of the two test or control groups. In the same way, this work will continue until the end of the sample size of the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, only the participants who are patients after shoulder rotator cuff tendon repair surgery are kept blind, so that first the study procedures are fully explained to the participants and the study groups are introduced to them in detail, but after their consent In order to participate in the study, in the stage of determining the group, the patients are randomly assigned to the test and control groups without knowing their group. Both groups do common exercises, and people in the test group do more exercises under the name of kinetic chain exercises. Since the therapist, evaluator and analyst is a researcher, she cannot be kept blind. In addition, in order to comply with ethical issues, after the end of the study, the control group will also receive additional treatment of the intervention group
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Tarbiat Modares University
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran
City
tehran
Province
Tehran
Postal code
1411713116
Approval date
2023-05-29, 1402/03/08
Ethics committee reference number
IR.MODARES.REC.1402.037

Health conditions studied

1

Description of health condition studied
Shoulder rotator cuff tear
ICD-10 code
M75.11
ICD-10 code description
Incomplete rotator cuff tear or rupture not specified as traumatic

Primary outcomes

1

Description
Scapulohumeral Rythm
Timepoint
Before the start of the intervention and 4 weeks after it
Method of measurement
Motion Analysis System

2

Description
Muscle Activation Pattern
Timepoint
Before the start of the intervention and 4 weeks after it
Method of measurement
EMG (Electromyography)

3

Description
Passive Shoulder Range of Motion
Timepoint
Before the start of the intervention and 4 weeks after it
Method of measurement
Goniometer

4

Description
pain
Timepoint
Before the start of the intervention and 4 weeks after it
Method of measurement
Visual Analog Scale

5

Description
Shoulder Functional Abilities
Timepoint
Before the start of the intervention and 4 weeks after it
Method of measurement
DASH Questionnaire

6

Description
Quality of Life
Timepoint
Before the start of the intervention and 4 weeks after it
Method of measurement
SF-36 Quality of Life Questionnaire

Secondary outcomes

1

Description
Shoulder Functional Abilities Score
Timepoint
before start of the intervention and 4 weeks after it
Method of measurement
DASH Questionnaire

2

Description
Quality of Life Score
Timepoint
before start of the intervention and 4 weeks after it
Method of measurement
SF-36 Quality of Life Questionnaire

Intervention groups

1

Description
Control group: This group includes patients after shoulder rotator cuff tendon surgery, who for 6 weeks (3 sessions of 90 minutes each week) in the first phase after surgery, based on the ASSET protocol, receive treatments including CPM device, therapeutic exercises and manual therapy by a physiotherapist. All movements in this phase are passive. Then the first evaluation session is performed, and patients enter the second phase of the ASSET protocol and receive CPM treatments, exercise therapy and manual therapy for 4 weeks (12 sessions of 90 minutes). The movements of this stage are active-assisted and active. At the end, the second assessment session is conducted
Category
Rehabilitation

2

Description
Intervention group: This group also includes patients after shoulder rotator cuff tendon surgery who receive all the treatments of the control group with the same timing. The intervention group in the second phase, which is after the 6th week and for 4 weeks (12 sessions of 120 minutes), in addition to the ASSET protocol exercises, perform 8 kinetic chain exercises with 10 repetitions each. The evaluation sessions are done exactly the same as the control group
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tarbiat Modares University
Full name of responsible person
Farid Bahrpeima
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 0000
Email
bahrpeyf@modares.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modares University Research Assistant
Full name of responsible person
Farid Bahrpeima
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 0000
Email
bahrpeyf@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University Research Assistant
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Nazanin Fatemeh Afshari
Position
PHD Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No.71, 7th Floor, Block 604, 6th phase, Buali Town, Saadat Abad, Tehran,
City
Tehran
Province
Tehran
Postal code
1981979383
Phone
+98 21 2207 5231
Email
afshary@modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Nazanin Fatemeh Afshari
Position
PHD Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No.71, 7th Floor, Block 604, Phase 6, Boali Town, Saadat Abad, Tehran
City
Tehran
Province
Tehran
Postal code
1981979383
Phone
+98 21 2207 5231
Fax
Email
afshary@modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Nazanin Fatemeh Afshari
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No.71, 7th Floor, Block 604, Phase 6, Boali Town, Saadat Abad, Tehran
City
Tehran
Province
Tehran
Postal code
1981979383
Phone
+98 21 2207 5231
Fax
Email
afshary@modares.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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