Comparison of Surgery versus cervical collar treatment in Hirayama Disease (a medical condition with weakness and wasting of arms and/or hands)
Phase 3
- Conditions
- Health Condition 1: G128- Other spinal muscular atrophies and related syndromes
- Registration Number
- CTRI/2023/08/056849
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
(1)Age = 18 years
(2)Patients with Hirayama disease as per the following criteria (All of the following):
a.Clinical evidence of wasting and weakness confined to one limb (EMG evidence of denervation in the opposite limb will not be a reason for exclusion)
b.Progressive course, or initial progression followed by stationary course; and
c.No evidence of a compressive lesion of the spinal cord.
(3)Disease duration of =4 years
(4)Progression of clinical symptoms in the past six-months
Exclusion Criteria
Any of the following:
(1)Refusal to consent for randomization.
(2)Not willing to come for three- and six-months follow-up.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)To determine & compare the efficacy of posterior cervical fixation versus cervical collar in patients with Hirayama disease in terms of Odom’s criteria at six months after randomization.Timepoint: Six months
- Secondary Outcome Measures
Name Time Method 1)To determine & compare the efficacy of posterior cervical fixation versus cervical collar in patients with Hirayama disease in terms of Odom’s criteria at three months after randomization.Timepoint: Three months;2) To compare MRI DTI parameter in two groupsTimepoint: Six months;3) Compare clinical & electrophysiological features in two groupsTimepoint: Six months