Dry Needling Effects Post-traumatic Brain Injury
Primary Purpose
Traumatic Brain Injury
Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Dry needling
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria:
- Traumatic brain injury
Exclusion Criteria:
- Unstable status
Sites / Locations
- Isra University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dry needling
Arm Description
Outcomes
Primary Outcome Measures
modified Ashworth Scale (MAS)
Spasticity for the upper and lower limbs was evaluated using the modified Ashworth Scale (MAS) (Ghotbi, 2009). The scale evaluates the resistance of a limb to a rapid passive stretch in 6 scores from 0 to 5. Score 0 indicates normal muscle tone, and 5 indicates rigid limb (Bohannon, 1987). The MAS for a patient with TBI has shown good reliability (ICC = 0.62-0.90) (Mehrholz, 2005).
Secondary Outcome Measures
6-Minute Walk Teat (6-MWT)
The 6-Minute Walk Teat (6-MWT) was the distance covered by the patient in 6 minutes. It was used to evaluate functional capacity in individuals with chronic disorders (Danielsson, 2007). The 6-MWT is a good predictor of cardiorespiratory endurance in patients with TBI (Mossberg, 2012). The 6-MWT for a patient with TBI has shown good reliability (ICC = 0.96-0.98) and good discriminant validity (Bartels, 2012). The test was applied according to the guidelines provided by of American Thoracic Society (ATS) (ATS Statement,2002). Two reference points were placed at 30 m from each other. Before and immediately following the test, heart rate and oxygen saturation were taken using a pulse oximeter. The patient was able to complete the 6-MWT without taking a rest break. Gait speed was demonstrated in meters per minute by dividing the total distance covered in the 6-MWT by 6 minutes.
Berg Balance Scale (BBS)
The balance and risk of falls were evaluated using Berg Balance Scale (BBS). This scale includes 14 items requiring patients to complete tasks related to the everyday life of varying difficulty levels. The total final scores range from 0 to 56. A total score of fewer than 45 exhibits balance impairment (Berg,1989; Zwick,2000). The BBS has excellent reliability (ICC = 0.986) in patients with TBI (Newstead,2005).
Functional Independence Measure (FIM)
The Functional Independence Measure (FIM) is a tool that measures the individual's degree of dependency. Thirteen tasks belong to a motor and 5 to a cognitive element. Each activity is evaluated on a 7-point scale ranging from 1 (complete dependency) to 7 (complete autonomy). A total scores range from 18 to 126, corresponding to 13-91 for the motor subscore and 5-35 for the cognitive sub-score (Hamilton, 1987).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05460728
Brief Title
Dry Needling Effects Post-traumatic Brain Injury
Official Title
Dry Needling Effects on Spasticity and General Functioning in Patients With Traumatic Brain Injury: A Case Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 5, 2022 (Actual)
Primary Completion Date
July 8, 2022 (Actual)
Study Completion Date
July 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anas Radi Hassan Alashram
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Thirty-six years old male with a history of TBI with compromised functionality of the right upper and lower limbs, spasticity, distributed balance, and difficulties performing independent gait has participated in the study. Berg balance scale, 6-minute walk test, modified Ashworth scale, and functional independence measure was used to assess balance, gait, spasticity, and functional intemperance, respectively.
Detailed Description
A 36-year-old man (height: 1.75 m, weight: 73 kg) with a 6-month history of TBI due to a motor vehicle accident resulting in right hemiplegia was admitted in March 2022 to the outpatient Neurological Physiotherapy Clinic. He was alert and oriented and had expressive aphasia. The patient had compromised functionality of the right upper and lower limbs, spasticity, distributed balance, and difficulties performing independent gait. He was right-hand dominant.
Demographic data were recorded including age, gender, occupation, and duration of disease. The outcome measures were evaluated at baseline (T0), 12 weeks from T0 (T1), and 16 weeks from T0 (4 weeks after the intervention, T2).
Spasticity assessment Spasticity for the upper and lower limbs was evaluated using the modified Ashworth Scale (MAS). The scale evaluates the resistance of a limb to a rapid passive stretch in 6 scores from 0 to 5. Score 0 indicates normal muscle tone, and 5 indicates rigid limb. The MAS for a patient with TBI has shown good reliability (ICC = 0.62-0.90).
Gait and balance assessment The primary outcome of the 6-MWT was the distance covered by the patient in 6 minutes. It was used to evaluate functional capacity in individuals with chronic disorders. The 6-MWT is a good predictor of cardiorespiratory endurance in patients with TBI. The 6-MWT for a patient with TBI has shown good reliability (ICC = 0.96-0.98) and good discriminant validity. The test was applied according to the guidelines provided by of American Thoracic Society (ATS). Two reference points were placed at 30 m from each other. Before and immediately following the test, heart rate and oxygen saturation were taken using a pulse oximeter. The patient was able to complete the 6-MWT without taking a rest break. Gait speed was demonstrated in meters per minute by dividing the total distance covered in the 6-MWT by 6 minutes.
The balance and risk of falls were evaluated using Berg Balance Scale (BBS). This scale includes 14 items requiring patients to complete tasks related to the everyday life of varying difficulty levels. The total final scores range from 0 to 56. A total score of fewer than 45 exhibits balance impairment. The BBS has excellent reliability (ICC = 0.986) in patients with TBI.
Independence measure The Functional Independence Measure (FIM) is a tool that measures the individual's degree of dependency. Thirteen tasks belong to a motor and 5 to a cognitive element. Each activity is evaluated on a 7-point scale ranging from 1 (complete dependency) to 7 (complete autonomy). A total scores range from 18 to 126, corresponding to 13-91 for the motor subscore and 5-35 for the cognitive sub-score.
Intervention The intervention was performed in an outpatient Neurological Physiotherapy Clinic, Amman, Jordan, by a skilled physical therapist. The MTrPs were detected in the upper and lower limbs based on the DNT criteria for spasticity: 1) Fundamental criteria: Limitation to passive stretching or activating of myotatic reflex and tight muscle band, and 2) Affirmative criteria: visual or tactile identification of global or focal twitch response when inserting the needle, and neural release (i.e. immediate release from contraction).
A three-weekly session of DNT was administered with an acupuncture needle (0.30 × 50 mm; Huan Qiu, Suzhou, China). For each session, DNT was applied in the deltoid, biceps brachialis, wrist extensors and flexors, thenar muscles, vastus medialis, gastrocnemius medialis, and tibialis anterior. Following focal twitch responses (maximum three), the dry needle was left inserted for 15 minutes in each muscle.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dry needling
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
A three-weekly session of DNT was administered with an acupuncture needle (0.30 × 50 mm; Huan Qiu, Suzhou, China). For each session, DNT was applied in the deltoid, biceps brachialis, wrist extensors and flexors, thenar muscles, vastus medialis, gastrocnemius medialis, and tibialis anterior (Hong, 1994). Following focal twitch responses (maximum three), the dry needle was left inserted for 15 minutes in each muscle.
Primary Outcome Measure Information:
Title
modified Ashworth Scale (MAS)
Description
Spasticity for the upper and lower limbs was evaluated using the modified Ashworth Scale (MAS) (Ghotbi, 2009). The scale evaluates the resistance of a limb to a rapid passive stretch in 6 scores from 0 to 5. Score 0 indicates normal muscle tone, and 5 indicates rigid limb (Bohannon, 1987). The MAS for a patient with TBI has shown good reliability (ICC = 0.62-0.90) (Mehrholz, 2005).
Time Frame
Change from baseline MAS at 12-week and 16-week
Secondary Outcome Measure Information:
Title
6-Minute Walk Teat (6-MWT)
Description
The 6-Minute Walk Teat (6-MWT) was the distance covered by the patient in 6 minutes. It was used to evaluate functional capacity in individuals with chronic disorders (Danielsson, 2007). The 6-MWT is a good predictor of cardiorespiratory endurance in patients with TBI (Mossberg, 2012). The 6-MWT for a patient with TBI has shown good reliability (ICC = 0.96-0.98) and good discriminant validity (Bartels, 2012). The test was applied according to the guidelines provided by of American Thoracic Society (ATS) (ATS Statement,2002). Two reference points were placed at 30 m from each other. Before and immediately following the test, heart rate and oxygen saturation were taken using a pulse oximeter. The patient was able to complete the 6-MWT without taking a rest break. Gait speed was demonstrated in meters per minute by dividing the total distance covered in the 6-MWT by 6 minutes.
Time Frame
Change from baseline 6-MWT at 12-week and 16-week
Title
Berg Balance Scale (BBS)
Description
The balance and risk of falls were evaluated using Berg Balance Scale (BBS). This scale includes 14 items requiring patients to complete tasks related to the everyday life of varying difficulty levels. The total final scores range from 0 to 56. A total score of fewer than 45 exhibits balance impairment (Berg,1989; Zwick,2000). The BBS has excellent reliability (ICC = 0.986) in patients with TBI (Newstead,2005).
Time Frame
Change from baseline BBS at 12-week and 16-week
Title
Functional Independence Measure (FIM)
Description
The Functional Independence Measure (FIM) is a tool that measures the individual's degree of dependency. Thirteen tasks belong to a motor and 5 to a cognitive element. Each activity is evaluated on a 7-point scale ranging from 1 (complete dependency) to 7 (complete autonomy). A total scores range from 18 to 126, corresponding to 13-91 for the motor subscore and 5-35 for the cognitive sub-score (Hamilton, 1987).
Time Frame
Change from baseline FIM at 12-week and 16-week
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Traumatic brain injury
Exclusion Criteria:
Unstable status
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANAS RADI H Annino
Organizational Affiliation
University of Rome Tor Vergata
Official's Role
Study Director
Facility Information:
Facility Name
Isra University
City
Amman
ZIP/Postal Code
11199
Country
Jordan
12. IPD Sharing Statement
Plan to Share IPD
No
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Dry Needling Effects Post-traumatic Brain Injury
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