Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05460728 |
| Other study ID # |
SREC/22/05/041 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 5, 2022 |
| Est. completion date |
July 9, 2022 |
Study information
| Verified date |
July 2022 |
| Source |
Middle East University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
